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CompletedNCT03287310Updated Mar 1, 2021Results posted

First Time in Human (FTIH) Study to Evaluate Safety, Tolerability, Immunogenicity, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3511294 Administered Subcutaneously (SC) in Subjects With Mild to Moderate Asthma

A Phase 1 interventional study of GSK3511294 and Placebo in Asthma, sponsored by GlaxoSmithKline. Completed at 5 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-03-01.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

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Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 10 studies testing depemokimab in Asthma — 3 open to participants now, 3 under way, 3 of them phase 3. depemokimab · Asthma.

Enrollment
8th of 10
50 · median 273
Started
2017
the only one that year
Phase 1
3 of 10
none open now
Registered
1st of 10
by date
Lead sponsor
10 of 10
GlaxoSmithKline

Among the 10 studies testing depemokimab in Asthma, this one is the 8th largest by enrollment, is the only one that started in 2017, is one of 3 in phase 1, and was the 1st registered.

Asthma

4,846 studies on the registry are indexed under Asthma; 603 are open to participants now.

Browse Asthma studies →

Open to participants now

3 of the 10 studies testing depemokimab in Asthma are open now, in 12 countries. Recruiting first, the newest first:

By country, each count listing its studies:

United States3
United Kingdom2
Belgium1
Canada1
China1
France1
Germany1
Greece1
Italy1
Korea, Republic of1
Spain1
Taiwan1

All 3 open studies →

About depemokimab

depemokimab: first FDA approval 2025 (EXDENSUR), first EMA approval 2026. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 147 take children under 18; 105 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies testing depemokimab in Asthma, or all of them as a file.
02

Study summary

GSK3511294 is a humanized monoclonal antibody antagonist of Interleukin (IL)-5 which is known to block binding of IL-5 to the IL-5 receptor complex, causing a reduction in the circulating population of eosinophils. This is a single ascending dose FTIH study to investigate safety, tolerability, immunogenicity, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK3511294, administered SC in subjects with mild to moderate asthma maintained on a low-medium daily dose of inhaled corticosteroids (ICS) or ICS/long acting beta-agonist (LABA), and short acting beta-agonist (SABA). The subjects will attend a pre-screen visit of up to 12 weeks before dosing for assessment of blood eosinophils. Eligible subjects with blood eosinophils >=200 cells per microliter (cells/µL) will undergo a screening period of up to 4 weeks. The subjects will then be randomized into 5 cohorts. In each cohort, the subjects will be randomized to receive a single dose of GSK3511294 or placebo in a ratio of 3:1. The follow-up period will be up to 40 weeks post dose and will be dose-dependent. The scheduled maximum duration for each subject will be up to 44 weeks including up to 28 days of screening.

03

Conditions studied

  • Asthma

Browse trials for

Keywords

  • eosinophils
  • pharmacokinetics
  • First time in Human
  • GSK3511294
  • pharmacodynamics
  • asthma
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects should be between 18 and 65 years of age inclusive, at the time of signing the .
  • Blood eosinophils of >= 200 cells/µL at screening.
  • A physician diagnosis of asthma (mild or moderate, as defined by the Global Initiative for Asthma [GINA], 2017) at least 12 months prior to the start of the study. The reason for diagnosis of asthma should be documented in the subject's source data, including relevant history and investigations - specifically evidence of airway hyper-responsiveness, airflow variation (peak flow rate or [FEV1]) or reversible airflow obstruction should also be documented in the subject's source data.
  • A screening pre-bronchodilator FEV1 >= 60% of predicted normal value.
  • Asthma Control Test score > 19.
  • hsCRP of \< 10 milligrams per liter (mg/L) at screening.
  • Otherwise healthy (other than the acceptable conditions of asthma and other atopic diseases, including allergic rhinitis and atopic dermatitis) based on a screening medical history, physical examination, vital signs, assessment, pulmonary function testing, and clinical laboratory results.
  • Maintained controlled on as needed SABA and one of the following: a) stable dose of ICS; b) stable dose of combination therapy: ICS/LABA.
  • Body weight >= 50 kilograms (kg), and (BMI) of 19-32 kilograms per square meter (kg/m\^2) inclusive.
  • Male and female subjects. a) a female subject is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of . b) as GSK3511294 is a monoclonal antibody that is not anticipated to interact directly with Deoxyribonucleic acid (DNA) or other chromosomal material with minimal exposure through semen expected, male subjects will not be required to use during the study, nor are they prohibited from donating sperm.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions of the study.

Exclusion criteria

Exclusion Criteria:

  • Any asthma exacerbation requiring systemic within 12 weeks of screening, or that resulted in overnight hospitalization requiring additional treatment for asthma within 6 months prior to screening.
  • A history of life-threatening asthma defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 5 years.
  • Significant pulmonary diseases, other than asthma, including (but not limited to): pneumonia previously requiring hospital admission, pulmonary fibrosis, bronchopulmonary dysplasia, chronic bronchitis, emphysema, , or other significant respiratory abnormalities.
  • Suspected or confirmed bacterial or viral infection (including tuberculosis) of the upper or lower respiratory tract, sinus or middle ear that occurred within and/or has not resolved within 4 weeks of screening that: led to a change in asthma management or in the opinion of the Investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study.
  • Positive for surface antigen (HBsAg) at screening.
  • Positive antibody test result at screening, or within 3 months prior to first dose of study treatment.
  • Known immunodeficiency (other than that explained by the use of corticosteroids), including a positive test for (HIV) antibody at screening.
  • Latent or chronic infections (example, genital herpes, urinary tract infections) or at risk of infection (example, significant trauma or infection within the 90 days before screening).
  • Opportunistic infection within 6 months prior to screening (example, a non-tuberculous mycobacterial infection or cytomegalovirus, pneumocystosis, aspergillosis).
  • Parasitic infestation within 6 months prior to screening, or have travelled to a country with a high prevalence of such infections in the 6 months before screening, or intend to do so in the year after dosing.
  • within 4 weeks prior to screening, or intention to receive live vaccine during the study.
  • by Fridericia's formula (QTcF) interval > 450 milliseconds (msec)
  • A personal history of severe hypertension, arrhythmia, Right Bundle Branch Block, or Left Bundle Branch Block, or a family history of sudden unexplained death, long QT, familial cardiac syndrome, or cardiomyopathy.
  • >1.5 times (ULN).
  • >1.5 times ULN. Isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%.
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Any history or presence of cardiac or cardiovascular, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease or immunodeficiency, or signs of acute illness, or any other illness or condition that, in the opinion of the investigator (in consultation with the medical monitor), would adversely affect the subject's participation in this study.
  • A previous history of cancer in remission for less than 5 years prior to screening (except for localized carcinoma of the skin that had been resected for cure) or current .
  • A positive drug/alcohol test before dosing, OR any history of drug abuse OR regular alcohol consumption within 6 months of the study defined as: An average weekly intake of > 14 units alcohol. One unit is equivalent to 8 grams (g) of alcohol: a half-pint (equivalent to 240 milliliters [mL]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
  • Current smokers or ex-smokers who have given up smoking for \< 12 months and/or have a smoking pack history of > 5 pack years (1 pack year = 20 cigarettes per day for 1 year or 5 cigarettes per day for 4 years).
  • Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
  • Anticipated non-availability and/or risk of non-compliance with study visits and procedures, or unwillingness or inability to follow the study specific procedures.
  • The subject has participated in a clinical trial and has received an product within the following time period prior to the first dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Exposure to more than 4 investigational medicinal products within 12 months prior to the first dosing day.
  • History of sensitivity to any of the study medications, or its components, or a history of drug reaction or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
  • Major surgery within 90 days prior to screening, or planned in-patient surgery or hospitalization during the study period
  • Donation or loss of blood or blood products in excess of 500 mL within the 3 months before dosing.
  • History of renal disease, abnormal kidney function or evidence of persisting or clinically relevant protein or blood on urinalysis.
  • History or signs of immunologically active disease (including the presence of low C3 or low C4) or thrombocytopenia.
  • History of vasculitis.
  • Subjects are excluded if they are undergoing desensitization therapy, or have received any of the following medications as indicated prior to screening: anti- Immunoglobulin E (IgE) therapy (within 6 months); anti-IL5 (within 6 months); oral or injectable corticosteroids (within 8 weeks); long acting muscarinic antagonist (LAMA) or leukotriene receptor antagonist (LTRA) therapy (within 8 weeks); drugs that can prolong the QT interval.
  • Subjects who are employees of the sponsor or clinical unit are excluded.
  • Vulnerable subjects, e.g., participants kept in detention, protected adults under guardianship, trusteeship and soldiers, or participants committed to an institution by governmental or juridical order.
Terms in these criteria, in plain language(19)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Subjects receiving GSK3511294 in Cohort 1

    Six subjects in Cohort 1 will receive a single SC dose of 2 mg GSK3511294.

    Drug: GSK3511294 · Drug: Salbutamol/albuterol

  • Placebo comparator
    Subjects receiving placebo in Cohort 1

    Two subjects in Cohort 1 will receive a single SC dose of placebo.

    Drug: Placebo · Drug: Salbutamol/albuterol

  • Experimental
    Subjects receiving GSK3511294 in Cohort 2

    Six subjects in Cohort 2 will receive a single SC dose of 10 mg GSK3511294.

    Drug: GSK3511294 · Drug: Salbutamol/albuterol

  • Placebo comparator
    Subjects receiving placebo in Cohort 2

    Two subjects in Cohort 2 will receive a single SC dose of placebo.

    Drug: Placebo · Drug: Salbutamol/albuterol

  • Experimental
    Subjects receiving GSK3511294 in Cohort 3

    Nine subjects in Cohort 3 will receive a single SC dose of 30 mg GSK3511294.

    Drug: GSK3511294 · Drug: Salbutamol/albuterol

  • Placebo comparator
    Subjects receiving placebo in Cohort 3

    Three subjects in Cohort 3 will receive a single SC dose of placebo.

    Drug: Placebo · Drug: Salbutamol/albuterol

  • Experimental
    Subjects receiving GSK3511294 in Cohort 4

    Nine subjects in Cohort 4 will receive a single SC dose of 100 mg GSK3511294.

    Drug: GSK3511294 · Drug: Salbutamol/albuterol

  • Placebo comparator
    Subjects receiving placebo in Cohort 4

    Three subjects in Cohort 4 will receive a single SC dose of placebo.

    Drug: Placebo · Drug: Salbutamol/albuterol

  • Experimental
    Subjects receiving GSK3511294 in Cohort 5

    Six subjects in Cohort 5 will receive a single SC dose of 300 mg GSK3511294.

    Drug: GSK3511294 · Drug: Salbutamol/albuterol

  • Placebo comparator
    Subjects receiving placebo in Cohort 5

    Two subjects in Cohort 5 will receive a single SC dose of placebo.

    Drug: Placebo · Drug: Salbutamol/albuterol

Interventions

  • DrugGSK3511294

    GSK3511294 will be available as a clear or opalescent, colorless or yellow to brown solution for injection at unit dose strength of 150 milligrams per milliliter (mg/mL). GSK3511294 will be diluted in 0.9% weight by volume (w/v) sodium chloride to achieve the desired concentration for administration. GSK3511294 will be administered by SC injection.

  • DrugPlacebo

    Matching Placebo will consist of 0.9% w/v sodium chloride which will be administered by the SC route.

  • DrugSalbutamol/albuterol

    Drug page: Albuterol

    Salbutamol/albuterol will be supplied to all subjects for use as rescue medication during the study.

06

What researchers measure

Primary outcomes

  1. Number of Participants With Adverse Events (AEs) and Serious AEs (SAE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before; is associated with liver injury and impaired liver function.

    Time frame: Up to Week 40

  2. Number of Participants With Adverse Events of Special Interest (AESI)

    AESIs were defined as Hypersensitivity (narrow) and Injection site reactions like hematoma and swelling.

    Time frame: Up to Week 40

  3. Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count

    Blood samples were collected at indicated time-points for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

  4. Change From Baseline in Red Blood Cell Count (RBC)

    Blood samples were collected at indicated time-points for analysis of hematology parameters like RBC count. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

  5. Change From Baseline in Mean Corpuscle Volume (MCV)

    Blood samples were collected at indicated time-points for analysis of hematology parameters like MCV. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

  6. Change From Baseline in Mean Corpuscle Hemoglobin (MCH)

    Blood samples were collected at indicated time-points for analysis of hematology parameters like MCH. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

  7. Change From Baseline in Hemoglobin

    Blood samples were collected at indicated time-points for analysis of hematology parameters like hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

  8. Change From Baseline in Hematocrit

    Blood samples were collected at indicated time-points for analysis of hematology parameters like hematocrit. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

  9. Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP)

    Blood samples were collected at indicated time-points for analysis of clinical parameters like hsCRP. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

  10. Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin

    Blood samples were collected at indicated time-points for analysis of clinical parameters like total protein and albumin. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

  11. Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine

    Blood samples were collected at indicated time-points for analysis of clinical parameters like total bilirubin, direct bilirubin and creatinine. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

  12. Urine Specific Gravity Analysis by Dipstick Method

    Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity.

    Time frame: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

  13. Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

    SBP and DBP were assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

  14. Change From Baseline in Temperature

    Temperature was assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

  15. Change From Baseline in Heart Rate

    Heart rate was assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

  16. Change From Baseline in Respiration Rate

    Respiration rate was assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

  17. Change From Baseline in Heart Rate: Electrocardiogram (ECG)

    12-lead ECG were performed in a supine position using an automated ECG machine that calculated the heart rate and measured PR, QRS, QT and corrected QT (QTc) intervals. ECG measurements were performed in triplicate. When multiple ECGs were performed at the same planned timepoint, the average value of each parameter was used. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at 2 and 8 hours on Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

  18. Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval

    12-lead ECG were performed in a supine position using an automated ECG machine that calculated PR interval, QRS interval, QT interval and QTcF interval. ECG measurements were performed in triplicate. When multiple ECGs were performed at the same planned timepoint, the average value of each parameter was used. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at 2 and 8 hours on Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

  19. Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)

    Blood samples were collected at indicated time-points for analysis of clinical parameters like ALP, AST and ALT. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

  20. Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium

    Blood samples were collected at indicated time-points for analysis of clinical parameters like glucose, calcium, potassium, sodium, BUN, and magnesium. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

    Time frame: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

  21. Number of Participants With Presence of Ketones, Glucose, Occult Blood, and Protein

    Urine samples were collected to analyze presence of ketones, occult blood, glucose, and protein in urine. In this dipstick test, the level of occult blood, glucose, ketones and urine protein in urine samples were recorded as negative, trace, 1+ and 2+ indicating proportional concentrations in urine. Only categories with abnormal significant values have been presented.

    Time frame: Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

  22. Urine Potential of Hydrogen (pH) Analysis by Dipstick Method

    Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).

    Time frame: Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

  23. Absolute Values of Complement (C)3 and C4

    Blood samples were collected at indicated timepoints for analysis for complement (C3 and C4). Baseline was defined as latest pre-dose assessment with a non-missing value.

    Time frame: Baseline and at Days 2, 3, 4 and 5; Weeks 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

Secondary outcomes

  1. Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK3511294 2 mg and 10 mg

    Blood samples were collected from participants at indicated time points and analyzed for AUC (0-inf). Pharmacokinetic parameters were calculated by standard non compartmental analysis. Pharmacokinetic Population included participants in the Safety population for whom a pharmcokinetic sample was obtained and analyzed.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

  2. AUC(0-inf) of GSK3511294 30 mg and 100 mg

    Blood samples were collected from participants at indicated time points and analyzed for AUC (0-inf). Pharmacokinetic parameters were calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

  3. AUC(0-inf) of GSK3511294 300 mg

    Blood samples were collected from participants at indicated time points and analyzed for AUC (0-inf). Pharmacokinetic parameters were calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose

  4. Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of GSK3511294 2 mg and 10 mg

    Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). Pharmacokinetic parameters were calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

  5. AUC(0-t) of GSK3511294 30 mg and 100 mg

    Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). Pharmacokinetic parameters were calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

  6. AUC(0-t) of GSK3511294 300 mg

    Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose

  7. Area Under the Concentration-time Curve From Time Zero to Week 4 (AUC[0-Week 4]) of GSK3511294

    Blood samples were collected from participants at indicated time points and analyzed for AUC (0-Week 4). Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, and 4 post-dose

  8. Area Under the Concentration-time Curve From Time Zero to Week 12 (AUC[0-Week 12]) of GSK3511294

    Blood samples were collected from participants at indicated time points and analyzed for AUC (0-Week 12). Pharmacokinetic parameters were calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8 and 12 post-dose

  9. Area Under the Concentration-time Curve From Time Zero to Week 26 (AUC [0-Week 26]) of GSK3511294

    Blood samples were collected from participants at indicated time points and analyzed for AUC (0-Week 26). Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26 post-dose

  10. Percentage of AUC (0-inf) Obtained by Extrapolation (%AUCex) of GSK3511294 2 mg and 10 mg

    Blood samples were collected from participants at indicated time points and analyzed for %AUCex. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

  11. %AUCex of GSK3511294 30 mg and 100 mg

    Blood samples were collected from participants at indicated time points and analyzed for %AUCex. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

  12. %AUCex of GSK3511294 300 mg

    Blood samples were collected from participants at indicated time points and analyzed for %AUCex. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose

  13. Maximum Observed Concentration (Cmax) of GSK3511294 2 mg and 10 mg

    Blood samples were collected from participants at indicated time points and analyzed for Cmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

  14. Cmax of GSK3511294 30 mg and 100 mg

    Blood samples were collected from participants at indicated time points and analyzed for Cmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

  15. Cmax of GSK3511294 300 mg

    Blood samples were collected from participants at indicated time points and analyzed for Cmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose

  16. Time of Occurrence of Cmax (Tmax) of GSK3511294 2 mg and 10 mg

    Blood samples were collected from participants at indicated time points and analyzed for Tmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

  17. Tmax of GSK3511294 30 mg and 100 mg

    Blood samples were collected from participants at indicated time points and analyzed for Tmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

  18. Tmax of GSK3511294 300 mg

    Blood samples were collected from participants at indicated time points and analyzed for Tmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose

  19. Time of Last Quantifiable Concentration (Tlast) of GSK3511294 2 mg and 10 mg

    Blood samples were collected from participants at indicated time points and analyzed for Tlast. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

  20. Tlast of GSK3511294 30 mg and 100 mg

    Blood samples were collected from participants at indicated time points and analyzed for Tlast. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

  21. Tlast of GSK3511294 300 mg

    Blood samples were collected from participants at indicated time points and analyzed for Tlast. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose

  22. Apparent Clearance Following Subcutaneous Dosing (CL/F) of GSK3511294 2 mg and 10 mg

    Blood samples were collected from participants at indicated time points and analyzed for CL/F. CL/F was calculated as dose divided by AUC(0-inf). Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

  23. CL/F of GSK3511294 30 mg and 100 mg

    Blood samples were collected from participants at indicated time points and analyzed for CL/F. CL/F was calculated as dose divided by AUC(0-inf). Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

  24. CL/F of GSK3511294 300 mg

    Blood samples were collected from participants at indicated time points and analyzed for CL/F. CL/F was calculated as dose divided by AUC(0-inf). Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose

  25. Apparent Volume of Distribution After Subcutaneous Administration (Vd/F) of GSK3511294 2 mg and 10 mg

    Blood samples were collected from participants at indicated time points and analyzed for Vd/F. Vd/F was calculated as dose divided by terminal elimination rate constant (lambda_z) \*AUC(0-inf). Pharmacokinetic parameters were calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

  26. Vd/F of GSK3511294 30 mg and 100 mg

    Blood samples were collected from participants at indicated time points and analyzed for Vd/F. Vd/F was calculated as dose divided by \[lambda_z \*AUC(0-inf)\]. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

  27. Vd/F of GSK3511294 300 mg

    Blood samples were collected from participants at indicated time points and analyzed for Vd/F. Vd/F was calculated as dose divided by \[lambda_z \*AUC(0-inf)\]. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose

  28. Terminal Phase Elimination Rate Constant (Lambda_z) of GSK3511294 2 mg and 10 mg

    Blood samples were collected from participants at indicated time points and analyzed for lambda_z. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

  29. Lambda_z of GSK3511294 30 mg and 100 mg

    Blood samples were collected from participants at indicated time points and analyzed for lambda_z. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

  30. Lambda_z of GSK3511294 300 mg

    Blood samples were collected from participants at indicated time points and analyzed for lambda_z. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose

  31. Terminal Phase Half-life (t1/2) of GSK3511294 2 mg and 10 mg

    Blood samples were collected from participants at indicated time points and analyzed for t1/2. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

  32. T1/2 of GSK3511294 30 mg and 100 mg

    Blood samples were collected from participants at indicated time points and analyzed for t1/2. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

  33. T1/2 of GSK3511294 300 mg

    Blood samples were collected from participants at indicated time points and analyzed for t1/2. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

    Time frame: Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose

  34. Ratio to Baseline in Absolute Blood Eosinophil Count

    Blood samples were collected at indicated time-points. Analysis was performed using a mixed model repeated measures analysis (MMRM) model on log-transformed data with fixed categorical effects of treatment, planned timepoint and treatment-by-planned timepoint interaction and fixed continuous covariates of log Baseline blood eosinophil count and log Baseline blood eosinophil count-by-planned timepoint interaction. Baseline is defined as the latest predose non-missing blood eosinophil count. Ratio to Baseline is defined as post-dose visit value divided by Baseline value. Pharmacodynamic Population included participants in the 'Safety' population for whom a post-dose pharmacodynamic (ie blood eosinophil) sample was obtained and analyzed.

    Time frame: Baseline, Days 2, 3, 4, 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36, and 40

  35. Number of Participants With Anti-drug Antibody (ADA) Binding to GSK3511294

    Serum samples were collected to determine the presence of anti-GSK3511294 binding antibodies using a validated bioanalytical method. Data for any time post-Baseline is reported. The results were categorized as negative, transient positive (defined as a single confirmatory positive immunogenic response that does not occur at the final study assessment) and persistent positive (defined as a confirmatory positive immunogenic response for at least 2 consecutive assessments or a single result at the final study assessment).

    Time frame: Up to Week 40

  36. Titers of Binding ADA to GSK3511294

    Serum samples were collected to determine the presence of anti-GSK3511294 binding antibodies using a validated bioanalytical method. Data for any time post-Baseline is reported. Titer was only measured when a positive result was found.

    Time frame: Up to Week 40

07

Results

Posted Mar 1, 2021

Participant flow

This was double-blind, placebo-controlled, single ascending dose study in participants with mild to moderate asthma to assess safety, tolerability, immunogenicity, pharmacokinetics and pharmcodynamics of GSK3511294 administered subcutaneously. The study was conducted in Germany and United Kingdom.

Participant flow — Overall Study
MilestonePlaceboGSK3511294 2 mgGSK3511294 10 mgGSK3511294 30 mgGSK3511294 100 mgGSK3511294 300 mg
Started1266996
Completed1266996
Not completed000000

Outcome measures

PrimaryNumber of Participants With Adverse Events (AEs) and Serious AEs (SAE)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before; is associated with liver injury and impaired liver function.

Time frame:
Up to Week 40
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs) and Serious AEs (SAE)
ParticipantsPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
Any AE1126894
Any SAE000000
PrimaryNumber of Participants With Adverse Events of Special Interest (AESI)

AESIs were defined as Hypersensitivity (narrow) and Injection site reactions like hematoma and swelling.

Time frame:
Up to Week 40
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events of Special Interest (AESI)
ParticipantsPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
Hypersensitivity000100
Injection Site Reaction: hematoma100001
Injection Site Reaction: swelling100001
PrimaryChange From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count

Blood samples were collected at indicated time-points for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Reported as:
Mean · Giga cells per liter
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Giga cells per literPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
Basophils, Day 2,n=12,6,6,8,9,6-0.006 ± 0.0247-0.020 ± 0.02970.003 ± 0.0103-0.003 ± 0.02380.001 ± 0.0302-0.018 ± 0.0160
Basophils, Day 3,n=12,6,6,9,9,60.002 ± 0.03560.003 ± 0.04500.010 ± 0.0126-0.003 ± 0.0260-0.003 ± 0.0224-0.007 ± 0.0121
Basophils, Day 4,n=12,6,6,8,8,6-0.003 ± 0.02960.002 ± 0.0214-0.008 ± 0.0325-0.004 ± 0.0207-0.001 ± 0.01360.002 ± 0.0214
Basophils, Day 5,n=11,6,6,9,9,6-0.020 ± 0.0224-0.008 ± 0.0204-0.020 ± 0.0141-0.009 ± 0.0196-0.003 ± 0.0255-0.025 ± 0.0164
Basophils, Week 1,n=12,6,6,9,9,5-0.001 ± 0.0257-0.017 ± 0.0207-0.018 ± 0.03060.002 ± 0.02910.001 ± 0.0162-0.006 ± 0.0055
Basophils, Week 2,n=12,6,5,9,9,6-0.006 ± 0.0215-0.018 ± 0.02040.000 ± 0.0274-0.004 ± 0.0224-0.007 ± 0.0158-0.007 ± 0.0137
Basophils, Week 4,n=12,6,5,9,9,6-0.010 ± 0.0316-0.002 ± 0.0232-0.004 ± 0.01670.002 ± 0.0172-0.006 ± 0.0265-0.010 ± 0.0126
Basophils, Week 8,n=12,6,6,9,9,60.005 ± 0.01830.007 ± 0.0266-0.022 ± 0.0271-0.010 ± 0.0122-0.002 ± 0.0186-0.015 ± 0.0138
Basophils, Week 12,n=12,5,6,9,9,50.002 ± 0.0229-0.014 ± 0.0297-0.008 ± 0.0147-0.003 ± 0.0245-0.004 ± 0.0142-0.006 ± 0.0055
Basophils, Week 18,n=12,6,6,9,9,6-0.002 ± 0.02290.010 ± 0.0310-0.012 ± 0.0160-0.001 ± 0.02670.010 ± 0.0278-0.005 ± 0.0105
Basophils, Week 24,n=11,6,6,9,9,6-0.005 ± 0.01570.002 ± 0.0264-0.005 ± 0.0288-0.004 ± 0.0313-0.001 ± 0.0154-0.018 ± 0.0117
Basophils, Week 26,n=12,6,6,9,9,6-0.004 ± 0.02840.002 ± 0.03060.000 ± 0.02190.008 ± 0.0383-0.002 ± 0.0199-0.008 ± 0.0133
Basophils, Week 32,n=6,6,6,0,0,6-0.002 ± 0.03760.010 ± 0.02100.005 ± 0.0339——-0.008 ± 0.0117
Basophils, Week 36,n=6,0,0,9,9,0-0.002 ± 0.0214——0.021 ± 0.0247-0.002 ± 0.0199—
Basophils, Week 40,n=2,0,0,0,0,60.000 ± 0.0000————-0.012 ± 0.0313
Eosinophils, Day 2,n=12,6,6,8,9,60.024 ± 0.1412-0.120 ± 0.0587-0.145 ± 0.0797-0.251 ± 0.1504-0.208 ± 0.1685-0.152 ± 0.0794
Eosinophils, Day 3,n=12,6,6,9,9,6-0.001 ± 0.1986-0.167 ± 0.0755-0.203 ± 0.0876-0.289 ± 0.0987-0.287 ± 0.1744-0.182 ± 0.0920
Eosinophils, Day 4,n=12,6,6,8,8,60.014 ± 0.1950-0.172 ± 0.0749-0.212 ± 0.1144-0.348 ± 0.1149-0.300 ± 0.1829-0.192 ± 0.0643
Eosinophils, Day 5,n=11,6,6,9,9,6-0.034 ± 0.1529-0.202 ± 0.0799-0.235 ± 0.1117-0.326 ± 0.1385-0.276 ± 0.1351-0.210 ± 0.0767
Eosinophils, Week 1,n=12,6,6,9,9,50.033 ± 0.1461-0.195 ± 0.0609-0.242 ± 0.1189-0.324 ± 0.1350-0.298 ± 0.1824-0.206 ± 0.0568
Eosinophils, Week 2,n=12,6,5,9,9,60.072 ± 0.1809-0.212 ± 0.0895-0.210 ± 0.0886-0.344 ± 0.1334-0.307 ± 0.1602-0.223 ± 0.0952
Eosinophils, Week 4,n=12,6,5,9,9,60.025 ± 0.1635-0.227 ± 0.0712-0.238 ± 0.1150-0.366 ± 0.1466-0.321 ± 0.1969-0.253 ± 0.0855
Eosinophils, Week 8,n=12,6,6,9,9,60.036 ± 0.1486-0.230 ± 0.0769-0.280 ± 0.1202-0.379 ± 0.1519-0.343 ± 0.1841-0.252 ± 0.1007
Eosinophils, Week 12,n=12,5,6,9,9,50.025 ± 0.1566-0.174 ± 0.0777-0.262 ± 0.1087-0.371 ± 0.1484-0.336 ± 0.1895-0.250 ± 0.1245
Eosinophils, Week 18,n=12,6,6,9,9,60.029 ± 0.1263-0.148 ± 0.0685-0.208 ± 0.1153-0.359 ± 0.1445-0.338 ± 0.1786-0.253 ± 0.1067
Eosinophils, Week 24,n=11,6,6,9,9,6-0.021 ± 0.1436-0.072 ± 0.0662-0.103 ± 0.1916-0.300 ± 0.1546-0.334 ± 0.1769-0.245 ± 0.1017
Eosinophils, Week 26,n=12,6,6,9,9,60.035 ± 0.1812-0.042 ± 0.0571-0.037 ± 0.2813-0.273 ± 0.1773-0.319 ± 0.1724-0.252 ± 0.0920
Eosinophils, Week 32,n=6,6,6,0,0,60.008 ± 0.09350.042 ± 0.11530.003 ± 0.2467——-0.235 ± 0.1205
Eosinophils, Week 36,n=6,0,0,9,9,0-0.045 ± 0.1758——-0.041 ± 0.2734-0.258 ± 0.1594—
Eosinophils, Week 40,n=2,0,0,0,0,60.245 ± 0.1344————-0.222 ± 0.1196
Lymphocytes, Day 2,n=12,6,6,8,9,6-0.010 ± 0.38970.135 ± 0.28860.108 ± 0.2185-0.061 ± 0.3165-0.157 ± 0.33360.100 ± 0.2804
Lymphocytes, Day 3,n=12,6,6,9,9,60.064 ± 0.44470.330 ± 0.35710.143 ± 0.1810-0.140 ± 0.2382-0.081 ± 0.41310.143 ± 0.3296
Lymphocytes, Day 4,n=12,6,6,8,8,60.006 ± 0.49630.193 ± 0.32420.172 ± 0.34740.005 ± 0.17530.005 ± 0.37980.210 ± 0.2772
Lymphocytes, Day 5,n=11,6,6,9,9,6-0.077 ± 0.47460.108 ± 0.23190.085 ± 0.1302-0.253 ± 0.29830.104 ± 0.44630.047 ± 0.1226
Lymphocytes, Week 1,n=12,6,6,9,9,50.048 ± 0.46280.295 ± 0.24040.058 ± 0.4116-0.060 ± 0.3248-0.018 ± 0.4217-0.154 ± 0.2587
Lymphocytes, Week 2,n=12,6,5,9,9,6-0.133 ± 0.41070.222 ± 0.35430.096 ± 0.4117-0.120 ± 0.3304-0.068 ± 0.41040.047 ± 0.1189
Lymphocytes, Week 4,n=12,6,5,9,9,6-0.189 ± 0.46160.088 ± 0.29380.056 ± 0.2899-0.062 ± 0.2346-0.052 ± 0.5189-0.137 ± 0.2103
Lymphocytes, Week 8,n=12,6,6,9,9,6-0.057 ± 0.46650.105 ± 0.2670-0.107 ± 0.3584-0.188 ± 0.22770.052 ± 0.3287-0.075 ± 0.0672
Lymphocytes, Week 12,n=12,5,6,9,9,5-0.142 ± 0.41070.228 ± 0.19680.072 ± 0.41130.014 ± 0.24900.048 ± 0.3231-0.388 ± 0.2237
Lymphocytes, Week 18,n=12,6,6,9,9,6-0.212 ± 0.4094-0.032 ± 0.2213-0.042 ± 0.3612-0.097 ± 0.40880.050 ± 0.4539-0.063 ± 0.1788
Lymphocytes, Week 24,n=11,6,6,9,9,6-0.179 ± 0.3876-0.028 ± 0.3616-0.040 ± 0.2744-0.070 ± 0.31020.052 ± 0.9838-0.132 ± 0.1619
Lymphocytes, Week 26,n=12,6,6,9,9,6-0.088 ± 0.4361-0.223 ± 0.3808-0.138 ± 0.3577-0.116 ± 0.49460.018 ± 0.5392-0.188 ± 0.2566
Lymphocytes, Week 32,n=6,6,6,0,0,6-0.165 ± 0.6851-0.057 ± 0.2842-0.197 ± 0.5467——-0.148 ± 0.2017
Lymphocytes, Week 36,n=6,0,0,9,9,00.007 ± 0.1838——-0.043 ± 0.43930.006 ± 0.4176—
Lymphocytes, Week 40,n=2,0,0,0,0,60.285 ± 0.3465————-0.125 ± 0.2966
Monocytes, Day 2,n=12,6,6,8,9,6-0.002 ± 0.09140.017 ± 0.13570.123 ± 0.12400.015 ± 0.11760.019 ± 0.07150.052 ± 0.1947
Monocytes, Day 3,n=12,6,6,9,9,60.029 ± 0.10010.028 ± 0.15330.100 ± 0.1235-0.028 ± 0.07530.032 ± 0.09520.018 ± 0.1514
Monocytes, Day 4,n=12,6,6,8,8,60.032 ± 0.0936-0.002 ± 0.12580.118 ± 0.1057-0.038 ± 0.09270.068 ± 0.10740.050 ± 0.0434
Monocytes, Day 5,n=11,6,6,9,9,6-0.034 ± 0.0841-0.025 ± 0.07010.053 ± 0.1299-0.100 ± 0.14700.074 ± 0.1874-0.035 ± 0.0766
Monocytes, Week 1,n=12,6,6,9,9,50.006 ± 0.09980.072 ± 0.11270.057 ± 0.17860.032 ± 0.05780.101 ± 0.1039-0.012 ± 0.0926
Monocytes, Week 2,n=12,6,5,9,9,60.013 ± 0.09450.050 ± 0.16210.056 ± 0.04510.004 ± 0.09750.118 ± 0.17380.090 ± 0.2697
Monocytes, Week 4,n=12,6,5,9,9,60.001 ± 0.07570.103 ± 0.1382-0.018 ± 0.08170.042 ± 0.05590.041 ± 0.1014-0.003 ± 0.1201
Monocytes, Week 8,n=12,6,6,9,9,60.048 ± 0.13770.123 ± 0.1681-0.053 ± 0.0484-0.006 ± 0.06480.080 ± 0.12110.058 ± 0.1509
Monocytes, Week 12,n=12,5,6,9,9,50.007 ± 0.10420.050 ± 0.0561-0.013 ± 0.08410.059 ± 0.08640.140 ± 0.17340.084 ± 0.1680
Monocytes, Week 18,n=12,6,6,9,9,60.042 ± 0.0897-0.040 ± 0.1362-0.045 ± 0.09440.018 ± 0.14750.092 ± 0.08740.043 ± 0.1516
Monocytes, Week 24,n=11,6,6,9,9,60.028 ± 0.1181-0.013 ± 0.09890.070 ± 0.09210.047 ± 0.13010.159 ± 0.25670.037 ± 0.0975
Monocytes, Week 26,n=12,6,6,9,9,60.040 ± 0.0888-0.037 ± 0.11290.010 ± 0.05510.036 ± 0.12670.121 ± 0.15000.013 ± 0.0720
Monocytes, Week 32,n=6,6,6,0,0,6-0.035 ± 0.0817-0.013 ± 0.16000.098 ± 0.0783——-0.012 ± 0.0662
Monocytes, Week 36,n=6,0,0,9,9,00.067 ± 0.0717——0.053 ± 0.16240.158 ± 0.2126—
Monocytes, Week 40,n=2,0,0,0,0,60.040 ± 0.0566————-0.032 ± 0.0873
Platelet, Day 2,n=12,5,5,9,9,6-9.7 ± 19.00-6.8 ± 10.40-6.4 ± 15.27-6.8 ± 17.996.1 ± 22.05-1.5 ± 19.32
Platelet, Day 3,n=12,5,6,9,9,6-2.8 ± 16.72-9.4 ± 8.295.7 ± 13.00-7.1 ± 19.981.7 ± 19.24-0.8 ± 19.60
Platelet, Day 4,n=12,5,5,8,8,6-5.6 ± 18.64-5.8 ± 3.636.6 ± 15.66-0.4 ± 18.86-1.1 ± 21.56-0.2 ± 6.62
Platelet, Day 5,n=12,5,6,9,9,6-7.6 ± 17.59-3.6 ± 13.89-3.0 ± 18.11-4.6 ± 19.096.2 ± 22.90-2.8 ± 18.62
Platelet, Week 1,n=12,5,6,9,8,6-0.9 ± 20.21-10.2 ± 11.305.0 ± 21.08-3.9 ± 12.4116.8 ± 25.37-13.8 ± 28.69
Platelet, Week 2,n=12,5,6,9,9,63.5 ± 16.512.8 ± 13.59-6.3 ± 29.38-0.9 ± 25.0925.0 ± 38.64-15.5 ± 39.81
Platelet, Week 4,n=12,5,4,9,9,6-11.5 ± 26.10-6.8 ± 20.931.3 ± 37.07-1.6 ± 17.6112.3 ± 35.87-5.0 ± 22.80
Platelet, Week 8,n=12,5,5,9,9,64.3 ± 22.8511.6 ± 23.712.6 ± 29.01-11.3 ± 21.0322.0 ± 30.81-3.5 ± 23.89
Platelet, Week 12,n=12,5,6,9,9,5-14.8 ± 26.42-6.0 ± 16.63-9.0 ± 26.83-10.8 ± 10.1527.4 ± 43.23-25.6 ± 24.39
Platelet, Week 18,n=12,5,6,9,9,6-8.6 ± 21.65-13.4 ± 20.42-14.0 ± 9.531.6 ± 19.5115.9 ± 22.452.2 ± 28.92
Platelet, Week 24,n=10,5,6,9,9,6-1.9 ± 14.81-7.8 ± 18.35-10.0 ± 14.97-1.6 ± 19.9419.7 ± 30.07-5.7 ± 39.38
Platelet, Week 26,n=12,5,6,9,9,62.4 ± 30.14-13.8 ± 17.70-19.3 ± 13.81-2.4 ± 12.2111.8 ± 36.37-6.8 ± 17.38
Platelet, Week 32,n=6,5,6,0,0,65.5 ± 18.71-0.6 ± 15.37-6.3 ± 10.39——-15.7 ± 51.15
Platelet, Week 36,n=6,0,0,9,9,0-1.8 ± 25.65——-0.3 ± 12.3713.9 ± 24.15—
Platelet, Week 40,n=2,0,0,0,0,6-20.0 ± 2.83————-11.7 ± 30.80
Neutrophil, Day 2,n=12,6,6,8,9,6-0.078 ± 0.88130.413 ± 0.6493-0.005 ± 0.92280.301 ± 0.50420.241 ± 0.82190.102 ± 0.4630
Neutrophil, Day 3,n=12,6,6,9,9,60.161 ± 0.45420.015 ± 0.66910.225 ± 0.68500.077 ± 0.95250.217 ± 1.10140.038 ± 0.5158
Neutrophil, Day 4,n=12,6,6,8,8,60.390 ± 0.48320.560 ± 0.46660.438 ± 0.92930.151 ± 0.94720.130 ± 1.04140.215 ± 0.4194
Neutrophil, Day 5,n=11,6,6,9,9,60.155 ± 0.77890.085 ± 0.6109-0.003 ± 0.34940.041 ± 0.70750.184 ± 1.08090.103 ± 0.2639
Neutrophil, Week 1,n=12,6,6,9,9,5-0.179 ± 0.6365-0.483 ± 1.2069-0.160 ± 0.3280-0.151 ± 0.59550.174 ± 0.89920.070 ± 0.4346
Neutrophil, Week 2,n=12,6,5,9,9,6-0.209 ± 0.4662-0.738 ± 0.7110-0.142 ± 1.0604-0.192 ± 0.94810.229 ± 0.8853-0.310 ± 0.6362
Neutrophil, Week 4,n=12,6,5,9,9,6-0.540 ± 0.4797-0.768 ± 0.7810-0.156 ± 0.9674-0.279 ± 0.5859-0.340 ± 0.70490.023 ± 0.7539
Neutrophil, Week 8,n=12,6,6,9,9,6-0.218 ± 0.78930.497 ± 1.6165-0.277 ± 0.9128-0.069 ± 1.0047-0.127 ± 0.58290.258 ± 0.5218
Neutrophil, Week 12,n=12,5,6,9,9,50.043 ± 0.9639-0.712 ± 0.58900.053 ± 1.0187-0.180 ± 0.4760-0.344 ± 0.4840-0.362 ± 0.5607
Neutrophil, Week 18,n=12,6,6,9,9,6-0.093 ± 0.9727-0.158 ± 0.77860.015 ± 0.7474-0.012 ± 0.8076-0.151 ± 0.5728-0.027 ± 0.6629
Neutrophil, Week 24,n=11,6,6,9,9,6-0.326 ± 0.4501-0.752 ± 0.9422-0.370 ± 0.3746-0.144 ± 0.52430.140 ± 0.5795-0.128 ± 0.4311
Neutrophil, Week 26,n=12,6,6,9,9,6-0.105 ± 0.7933-0.527 ± 0.6332-0.622 ± 0.6065-0.259 ± 0.93890.104 ± 0.7127-0.295 ± 0.2855
Neutrophil, Week 32,n=6,6,6,0,0,6-0.393 ± 0.8219-0.708 ± 0.77570.880 ± 1.9211——-0.360 ± 0.3275
Neutrophil, Week 36,n=6,0,0,9,9,0-0.163 ± 0.8441——-0.384 ± 0.4763-0.004 ± 0.9080—
Neutrophil, Week 40,n=2,0,0,0,0,6-0.005 ± 0.1061————0.332 ± 0.3452
PrimaryChange From Baseline in Red Blood Cell Count (RBC)

Blood samples were collected at indicated time-points for analysis of hematology parameters like RBC count. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Reported as:
Mean · Trillion cells per liter
Change From Baseline in Red Blood Cell Count (RBC)
Trillion cells per literPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
Day 2,n=12,6,6,9,9,6-0.08 ± 0.212-0.07 ± 0.1970.08 ± 0.2230.00 ± 0.1940.16 ± 0.2460.05 ± 0.243
Day 3,n=12,6,6,9,9,60.03 ± 0.214-0.08 ± 0.1330.13 ± 0.2420.01 ± 0.1900.06 ± 0.1330.03 ± 0.186
Day 4,n=12,6,6,8,8,6-0.04 ± 0.211-0.08 ± 0.1330.10 ± 0.179-0.03 ± 0.1490.04 ± 0.1850.10 ± 0.141
Day 5,n=12,6,6,9,9,6-0.18 ± 0.175-0.22 ± 0.133-0.10 ± 0.261-0.08 ± 0.1200.03 ± 0.3160.05 ± 0.187
Week 1,n=12,6,6,9,9,5-0.15 ± 0.215-0.37 ± 0.1750.00 ± 0.190-0.03 ± 0.2180.07 ± 0.180-0.02 ± 0.147
Week 2,n=12,6,6,9,9,6-0.11 ± 0.156-0.28 ± 0.133-0.18 ± 0.183-0.07 ± 0.2060.11 ± 0.232-0.08 ± 0.194
Week 4,n=12,6,5,9,9,6-0.18 ± 0.248-0.35 ± 0.055-0.16 ± 0.230-0.08 ± 0.1920.09 ± 0.293-0.03 ± 0.137
Week 8,n=12,6,6,9,9,6-0.03 ± 0.253-0.23 ± 0.186-0.02 ± 0.248-0.13 ± 0.2000.18 ± 0.2770.07 ± 0.103
Week 12,n=12,6,6,9,9,5-0.13 ± 0.176-0.25 ± 0.138-0.05 ± 0.251-0.01 ± 0.2370.19 ± 0.2370.00 ± 0.141
Week 18,n=12,6,6,9,9,6-0.02 ± 0.292-0.20 ± 0.219-0.08 ± 0.271-0.02 ± 0.2280.27 ± 0.2830.17 ± 0.163
Week 24,n=11,6,6,9,9,6-0.11 ± 0.221-0.27 ± 0.175-0.05 ± 0.1640.01 ± 0.1690.13 ± 0.2290.17 ± 0.151
Week 26,n=12,6,6,9,9,6-0.12 ± 0.301-0.33 ± 0.216-0.08 ± 0.204-0.02 ± 0.1200.20 ± 0.1940.12 ± 0.117
Week 32,n=6,6,6,0,0,6-0.10 ± 0.237-0.18 ± 0.1830.08 ± 0.248——0.05 ± 0.176
Week 36,n=6,0,0,9,9,00.12 ± 0.232——0.10 ± 0.1220.33 ± 0.357—
Week 40,n=2,0,0,0,0,6-0.05 ± 0.071————0.12 ± 0.098
PrimaryChange From Baseline in Mean Corpuscle Volume (MCV)

Blood samples were collected at indicated time-points for analysis of hematology parameters like MCV. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Reported as:
Mean · Femtoliters
Change From Baseline in Mean Corpuscle Volume (MCV)
FemtolitersPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
Day 2,n=12,6,6,9,9,60.2 ± 0.940.2 ± 0.750.2 ± 0.750.1 ± 2.85-0.3 ± 1.001.3 ± 2.16
Day 3,n=12,6,6,9,9,60.7 ± 1.07-0.3 ± 0.820.2 ± 0.750.0 ± 1.32-1.0 ± 1.410.3 ± 1.37
Day 4,n=12,6,6,8,8,60.3 ± 0.78-0.5 ± 1.050.0 ± 1.26-0.1 ± 0.83-1.8 ± 0.890.2 ± 0.98
Day 5,n=12,6,6,9,9,61.3 ± 1.920.5 ± 0.550.3 ± 0.822.0 ± 2.92-1.0 ± 3.500.7 ± 1.75
Week 1,n=12,6,6,9,9,6-0.2 ± 0.94-0.8 ± 1.330.2 ± 0.75-1.2 ± 1.20-1.7 ± 2.06-0.7 ± 1.21
Week 2,n=12,6,6,9,9,60.0 ± 1.28-0.3 ± 1.510.2 ± 0.75-0.9 ± 1.17-1.4 ± 2.51-0.3 ± 1.63
Week 4,n=12,6,5,9,9,60.7 ± 2.39-0.8 ± 2.140.2 ± 0.45-0.7 ± 0.87-1.6 ± 2.13-0.2 ± 0.98
Week 8,n=12,6,6,9,9,60.3 ± 1.23-0.3 ± 1.510.2 ± 0.750.0 ± 1.12-2.2 ± 2.91-0.2 ± 1.17
Week 12,n=12,6,6,9,9,50.5 ± 1.09-1.2 ± 1.940.2 ± 0.75-0.7 ± 1.87-2.4 ± 2.55-1.2 ± 0.84
Week 18,n=12,6,6,9,9,6-0.4 ± 1.73-0.8 ± 1.330.5 ± 1.64-1.9 ± 1.05-2.8 ± 3.07-1.0 ± 1.10
Week 24,n=11,6,6,9,9,6-0.8 ± 1.78-0.3 ± 1.860.8 ± 1.72-1.6 ± 1.51-2.4 ± 3.54-0.7 ± 1.03
Week 26,n=12,6,6,9,9,6-0.5 ± 2.240.0 ± 2.100.5 ± 0.84-1.7 ± 1.58-2.3 ± 3.04-0.3 ± 1.03
Week 32,n=6,6,6,0,0,60.5 ± 1.380.0 ± 2.450.8 ± 1.47——-0.2 ± 0.98
Week 36,n=6,0,0,9,9,0-1.5 ± 1.05——-1.9 ± 1.05-1.8 ± 2.44—
Week 40,n=2,0,0,0,0,6-0.5 ± 0.71————1.2 ± 0.75
PrimaryChange From Baseline in Mean Corpuscle Hemoglobin (MCH)

Blood samples were collected at indicated time-points for analysis of hematology parameters like MCH. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Reported as:
Mean · Picograms
Change From Baseline in Mean Corpuscle Hemoglobin (MCH)
PicogramsPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
Day 2,n=12,6,6,9,9,60.03 ± 0.5880.23 ± 0.3880.02 ± 0.299-0.04 ± 0.255-0.02 ± 0.277-0.07 ± 0.450
Day 3,n=12,6,6,9,9,60.13 ± 0.4850.25 ± 0.3890.10 ± 0.283-0.02 ± 0.2280.20 ± 0.444-0.08 ± 0.172
Day 4,n=12,6,6,8,8,60.14 ± 0.5420.17 ± 0.4800.18 ± 0.2990.05 ± 0.3510.01 ± 0.4320.12 ± 0.325
Day 5,n=12,6,6,9,9,60.08 ± 0.6260.17 ± 0.3140.22 ± 0.449-0.03 ± 0.3460.02 ± 0.331-0.22 ± 0.240
Week 1,n=12,6,6,9,9,5-0.07 ± 0.4330.38 ± 0.542-0.07 ± 0.2730.00 ± 0.3810.00 ± 0.427-0.08 ± 0.553
Week 2,n=12,6,6,9,9,6-0.02 ± 0.4950.33 ± 0.5160.25 ± 0.418-0.08 ± 0.331-0.04 ± 0.088-0.02 ± 0.240
Week 4,n=12,6,5,9,9,60.15 ± 1.1530.30 ± 0.3740.12 ± 0.268-0.29 ± 0.404-0.06 ± 0.394-0.22 ± 0.343
Week 8,n=12,6,6,9,9,6-0.06 ± 0.4290.25 ± 0.8600.30 ± 0.410-0.30 ± 0.287-0.11 ± 0.655-0.22 ± 0.286
Week 12,n=12,6,6,9,9,5-0.08 ± 0.5830.32 ± 0.8820.02 ± 0.624-0.42 ± 0.415-0.04 ± 0.541-0.60 ± 0.561
Week 18,n=12,6,6,9,9,6-0.13 ± 0.8050.78 ± 0.382-0.10 ± 0.616-0.37 ± 0.3840.01 ± 0.627-0.78 ± 0.382
Week 24,n=11,6,6,9,9,6-0.44 ± 0.8830.87 ± 0.7990.23 ± 0.356-0.37 ± 0.510-0.37 ± 0.632-0.90 ± 0.237
Week 26,n=12,6,6,9,9,6-0.27 ± 0.9461.05 ± 0.5050.10 ± 0.473-0.38 ± 0.432-0.71 ± 0.818-1.07 ± 0.393
Week 32,n=6,6,6,0,0,60.22 ± 0.9750.67 ± 0.6250.53 ± 0.909——-0.58 ± 0.331
Week 36,n=6,0,0,9,9,0-1.00 ± 0.525——-1.00 ± 0.403-0.68 ± 0.438—
Week 40,n=2,0,0,0,0,6-0.55 ± 0.071————-0.68 ± 0.232
PrimaryChange From Baseline in Hemoglobin

Blood samples were collected at indicated time-points for analysis of hematology parameters like hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Reported as:
Mean · Grams per liter
Change From Baseline in Hemoglobin
Grams per literPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
Day 2,n=12,6,6,9,9,6-2.4 ± 6.830.3 ± 6.803.7 ± 7.09-0.4 ± 6.004.3 ± 7.120.2 ± 8.52
Day 3,n=12,6,6,9,9,61.6 ± 6.78-0.5 ± 4.045.8 ± 8.800.1 ± 6.622.2 ± 4.35-0.5 ± 5.82
Day 4,n=12,6,6,8,8,6-0.8 ± 6.69-1.3 ± 4.593.7 ± 6.02-1.0 ± 4.141.4 ± 5.323.2 ± 5.12
Day 5,n=12,6,6,9,9,6-5.0 ± 4.65-4.8 ± 3.82-0.3 ± 7.84-2.9 ± 4.540.8 ± 8.86-0.3 ± 5.13
Week 1,n=12,6,6,9,9,6-4.9 ± 6.50-8.3 ± 5.280.2 ± 6.79-1.4 ± 7.002.0 ± 6.42-1.5 ± 3.27
Week 2,n=12,6,6,9,9,6-3.3 ± 5.79-6.2 ± 4.67-3.7 ± 5.72-2.4 ± 6.293.3 ± 7.73-3.5 ± 6.50
Week 4,n=12,6,5,9,9,6-4.2 ± 5.08-8.0 ± 4.10-3.0 ± 7.94-4.2 ± 6.612.6 ± 10.36-2.5 ± 4.09
Week 8,n=12,6,6,9,9,6-1.1 ± 8.83-4.8 ± 4.961.5 ± 8.71-5.6 ± 6.274.9 ± 7.80-0.2 ± 2.48
Week 12,n=12,6,6,9,9,5-4.3 ± 6.50-4.8 ± 4.49-0.2 ± 9.28-2.8 ± 7.985.9 ± 6.39-3.6 ± 2.07
Week 18,n=12,6,6,9,9,6-1.6 ± 8.47-1.8 ± 6.77-2.3 ± 6.62-2.4 ± 6.098.3 ± 9.250.5 ± 4.72
Week 24,n=11,6,6,9,9,6-5.3 ± 8.31-3.2 ± 7.990.5 ± 6.09-1.7 ± 6.362.4 ± 7.67-0.2 ± 3.37
Week 26,n=12,6,6,9,9,6-4.6 ± 9.70-4.5 ± 8.07-1.0 ± 5.76-2.2 ± 3.422.9 ± 6.23-2.7 ± 4.32
Week 32,n=6,6,6,0,0,6-1.7 ± 3.78-1.8 ± 4.795.2 ± 8.38——-1.8 ± 5.71
Week 36,n=6,0,0,9,9,0-1.8 ± 8.47——-2.4 ± 3.136.9 ± 10.67—
Week 40,n=2,0,0,0,0,6-3.5 ± 3.54————-0.2 ± 4.17
PrimaryChange From Baseline in Hematocrit

Blood samples were collected at indicated time-points for analysis of hematology parameters like hematocrit. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Reported as:
Mean · Proportion of red blood cells in blood
Change From Baseline in Hematocrit
Proportion of red blood cells in bloodPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
Day 2,n=12,6,6,9,9,6-0.007 ± 0.01961-0.001 ± 0.018840.009 ± 0.022620.000 ± 0.015000.011 ± 0.023560.007 ± 0.02689
Day 3,n=12,6,6,9,9,60.005 ± 0.01925-0.007 ± 0.013740.014 ± 0.026670.001 ± 0.01634-0.000 ± 0.011980.001 ± 0.01584
Day 4,n=12,6,6,8,8,6-0.003 ± 0.01777-0.009 ± 0.018030.005 ± 0.02170-0.003 ± 0.01663-0.004 ± 0.018580.008 ± 0.01251
Day 5,n=12,6,6,9,9,6-0.010 ± 0.01509-0.015 ± 0.01340-0.004 ± 0.027430.001 ± 0.01970-0.001 ± 0.032950.006 ± 0.01061
Week 1,n=12,6,6,9,9,6-0.014 ± 0.01894-0.034 ± 0.015490.000 ± 0.02138-0.008 ± 0.02644-0.001 ± 0.02068-0.005 ± 0.01076
Week 2,n=12,6,6,9,9,6-0.010 ± 0.01670-0.025 ± 0.01626-0.016 ± 0.01928-0.009 ± 0.019600.002 ± 0.02469-0.011 ± 0.01759
Week 4,n=12,6,5,9,9,6-0.011 ± 0.01840-0.032 ± 0.01393-0.010 ± 0.02192-0.010 ± 0.020630.001 ± 0.02962-0.004 ± 0.01315
Week 8,n=12,6,6,9,9,6-0.001 ± 0.02285-0.020 ± 0.02119-0.000 ± 0.02367-0.011 ± 0.018890.005 ± 0.030840.002 ± 0.00750
Week 12,n=12,6,6,9,9,5-0.010 ± 0.01745-0.025 ± 0.01262-0.001 ± 0.02587-0.005 ± 0.023790.006 ± 0.02343-0.006 ± 0.01279
Week 18,n=12,6,6,9,9,6-0.004 ± 0.02680-0.020 ± 0.02140-0.005 ± 0.03041-0.010 ± 0.020160.012 ± 0.029720.008 ± 0.01515
Week 24,n=11,6,6,9,9,6-0.013 ± 0.02108-0.023 ± 0.023250.001 ± 0.01955-0.006 ± 0.017260.001 ± 0.026070.009 ± 0.01184
Week 26,n=12,6,6,9,9,6-0.013 ± 0.02378-0.029 ± 0.02593-0.004 ± 0.01813-0.007 ± 0.014240.008 ± 0.018290.006 ± 0.01091
Week 32,n=6,6,6,0,0,6-0.005 ± 0.01904-0.015 ± 0.022200.009 ± 0.02413——0.002 ± 0.01851
Week 36,n=6,0,0,9,9,00.001 ± 0.01862——-0.001 ± 0.012370.022 ± 0.03464—
Week 40,n=2,0,0,0,0,6-0.004 ± 0.00495————0.016 ± 0.00816
PrimaryChange From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP)

Blood samples were collected at indicated time-points for analysis of clinical parameters like hsCRP. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Reported as:
Mean · Milligrams per liter
Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP)
Milligrams per literPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
Day 2,n=12,6,6,9,9,6-0.3443 ± 0.44689-0.1217 ± 0.28604-0.7367 ± 0.90943-0.3178 ± 0.45880-1.0956 ± 1.50219-0.4867 ± 0.50816
Day 3,n=11,6,6,9,9,6-0.4376 ± 0.43692-0.1417 ± 0.25818-0.8200 ± 1.10247-0.4367 ± 0.71042-1.4100 ± 2.19445-0.4817 ± 0.53663
Day 4,n=12,6,6,9,9,6-0.4570 ± 0.42874-0.1917 ± 0.23095-0.8683 ± 1.21224-0.5356 ± 0.91155-1.5311 ± 2.32545-0.5867 ± 0.66476
Day 5,n=12,6,6,9,9,6-0.3953 ± 0.37761-0.0117 ± 0.31244-0.7150 ± 1.23395-0.5322 ± 0.95860-1.4289 ± 2.35532-0.5867 ± 0.77590
Week 1,n=11,6,6,9,9,6-0.2176 ± 0.379600.2183 ± 0.23086-0.3033 ± 1.32284-0.5772 ± 0.86704-1.3156 ± 2.57735-0.5717 ± 0.69534
Week 2,n=12,6,6,9,9,60.0638 ± 0.446200.0167 ± 0.21435-0.6967 ± 1.306060.1733 ± 0.867810.2478 ± 2.91047-0.0967 ± 0.50091
Week 4,n=12,6,6,9,9,6-0.1253 ± 0.559020.1433 ± 0.66069-0.6433 ± 1.28969-0.2689 ± 0.868472.6422 ± 11.57024-0.4317 ± 0.54653
Week 8,n=12,6,6,9,9,60.5955 ± 1.622681.2817 ± 1.79930-0.3633 ± 1.66310-0.0878 ± 0.61243-1.1656 ± 2.91829-0.2517 ± 0.74440
Week 12,n=12,6,6,9,9,60.1455 ± 1.29507-0.1033 ± 0.367840.1250 ± 0.616560.9089 ± 1.31831-0.4067 ± 3.857250.1000 ± 0.55274
Week 18,n=12,6,6,9,9,60.1538 ± 0.544120.1883 ± 0.228510.1317 ± 1.770350.0700 ± 1.19067-1.1267 ± 2.89881-0.3300 ± 0.53457
Week 24,n=12,6,6,9,9,60.1163 ± 1.060520.4383 ± 1.46248-0.6383 ± 1.369020.1356 ± 0.80296-0.7989 ± 3.36420-0.2142 ± 1.09332
Week 26,n=12,6,6,9,9,60.2438 ± 0.755251.6333 ± 3.95614-0.6383 ± 1.137320.3344 ± 0.53761-0.6933 ± 3.253440.2400 ± 0.76467
Week 32,n=6,5,6,0,0,60.6393 ± 1.035140.2860 ± 0.82509-0.2400 ± 1.63862——-0.1367 ± 0.73277
Week 36,n=6,0,0,9,9,00.4917 ± 1.31750——-0.5456 ± 1.15831-0.1911 ± 3.93159—
Week 40,n=2,0,0,0,0,6-0.1450 ± 0.00707————0.4333 ± 1.74105
PrimaryChange From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin

Blood samples were collected at indicated time-points for analysis of clinical parameters like total protein and albumin. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Reported as:
Mean · Grams per liter
Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Grams per literPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
Total protein, Day 2,n=12,6,5,9,9,6-2.8 ± 3.74-2.3 ± 1.97-0.6 ± 3.36-3.8 ± 3.560.7 ± 4.90-0.2 ± 4.40
Total protein, Day 3,n=12,6,6,9,9,6-1.4 ± 3.68-2.5 ± 2.170.2 ± 3.43-1.7 ± 4.18-0.7 ± 3.160.0 ± 3.22
Total protein, Day 4,n=12,6,6,9,9,6-1.8 ± 4.34-1.2 ± 2.140.3 ± 2.58-2.8 ± 3.46-0.4 ± 2.651.7 ± 2.88
Total protein, Day 5,n=12,6,6,9,9,6-3.3 ± 2.77-2.7 ± 2.58-0.7 ± 4.72-3.2 ± 4.020.1 ± 5.780.0 ± 3.41
Total protein, Week 1,n=11,6,6,9,9,5-1.6 ± 2.87-2.3 ± 4.23-2.8 ± 2.99-1.2 ± 4.29-1.1 ± 3.62-1.4 ± 1.95
Total protein, Week 2,n=12,6,6,9,9,6-1.8 ± 3.28-2.8 ± 4.26-2.8 ± 2.99-1.2 ± 4.291.1 ± 4.08-1.0 ± 3.58
Total protein, Week 4,n=12,6,6,9,9,6-2.5 ± 3.48-3.3 ± 3.01-0.8 ± 5.19-1.4 ± 3.09-0.1 ± 4.78-1.0 ± 3.41
Total protein, Week 8,n=12,6,6,9,9,6-1.0 ± 4.33-0.8 ± 5.150.2 ± 4.54-3.0 ± 3.941.4 ± 3.751.2 ± 3.37
Total protein, Week 12,n=12,6,6,9,9,6-2.8 ± 2.67-3.5 ± 4.59-0.5 ± 3.62-2.6 ± 3.712.7 ± 2.780.0 ± 2.10
Total protein, Week 18,n=12,6,6,9,9,6-1.3 ± 2.56-1.8 ± 5.23-1.7 ± 3.20-2.0 ± 3.641.7 ± 3.501.5 ± 3.08
Total protein, Week 24,n=12,6,6,9,9,6-3.3 ± 3.79-2.8 ± 4.54-1.0 ± 3.35-2.7 ± 3.040.6 ± 3.710.3 ± 2.73
Total protein, Week 26,n=12,6,6,9,9,6-2.5 ± 3.55-3.5 ± 2.88-2.3 ± 3.39-3.7 ± 1.871.0 ± 2.400.3 ± 2.34
Total protein, Week 32,n=6,6,6,0,0,6-1.7 ± 3.930.0 ± 3.630.3 ± 5.09——-0.7 ± 2.66
Total protein, Week 36,n=6,0,0,9,9,0-1.5 ± 4.51——-2.6 ± 3.211.8 ± 3.77—
Total protein, Week 40,n=2,0,0,0,0,6-2.5 ± 3.54————0.7 ± 1.63
Albumin, Day 2,n=12,6,5,9,9,6-2.1 ± 2.68-1.3 ± 2.42-1.6 ± 2.07-2.4 ± 2.01-0.6 ± 3.36-0.5 ± 3.39
Albumin, Day 3,n=12,6,6,9,9,6-0.8 ± 2.70-1.3 ± 1.97-0.2 ± 2.48-1.4 ± 2.83-1.3 ± 2.06-0.3 ± 2.07
Albumin, Day 4,n=12,6,6,9,9,6-1.3 ± 2.63-0.5 ± 1.22-0.7 ± 1.86-2.2 ± 2.33-1.4 ± 1.810.3 ± 2.16
Albumin, Day 5,n=12,6,6,9,9,6-1.6 ± 1.68-1.5 ± 1.87-0.8 ± 3.54-2.3 ± 2.50-0.2 ± 3.49-0.2 ± 2.56
Albumin, Week 1,n=11,6,6,9,9,5-0.5 ± 2.34-0.2 ± 2.860.0 ± 2.68-2.2 ± 2.28-1.4 ± 2.07-1.4 ± 2.97
Albumin, Week 2,n=12,6,6,9,9,6-0.8 ± 2.25-0.2 ± 1.83-1.7 ± 2.16-0.8 ± 2.860.4 ± 1.88-0.5 ± 1.52
Albumin, Week 4,n=12,6,6,9,9,6-1.8 ± 2.42-1.0 ± 2.28-0.3 ± 2.88-1.3 ± 1.87-0.6 ± 2.19-1.3 ± 2.73
Albumin, Week 8,n=12,6,6,9,9,6-0.8 ± 2.73-0.3 ± 2.880.7 ± 2.94-2.0 ± 2.690.7 ± 2.830.7 ± 2.34
Albumin, Week 12,n=12,6,6,9,9,6-1.5 ± 1.73-1.3 ± 2.800.0 ± 2.45-1.7 ± 2.400.4 ± 1.33-0.2 ± 2.32
Albumin, Week 18,n=12,6,6,9,9,6-0.5 ± 2.35-0.3 ± 2.94-1.5 ± 1.64-0.7 ± 2.060.2 ± 2.440.2 ± 1.94
Albumin, Week 24,n=12,6,6,9,9,6-1.7 ± 2.190.3 ± 2.73-0.8 ± 2.32-2.0 ± 1.870.4 ± 2.79-0.2 ± 2.04
Albumin, Week 26,n=12,6,6,9,9,6-1.6 ± 2.27-0.8 ± 1.72-1.8 ± 2.93-2.1 ± 0.600.1 ± 1.69-0.3 ± 2.07
Albumin, Week 32,n=6,6,6,0,0,6-0.5 ± 3.021.2 ± 3.06-0.2 ± 2.93——-0.8 ± 2.14
Albumin, Week 36,n=6,0,0,9,9,0-0.7 ± 2.94——-1.4 ± 1.670.6 ± 2.40—
Albumin, Week 40,n=2,0,0,0,0,6-1.0 ± 2.83————-0.3 ± 1.63
PrimaryChange From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine

Blood samples were collected at indicated time-points for analysis of clinical parameters like total bilirubin, direct bilirubin and creatinine. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Reported as:
Mean · Micromoles per liter
Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Micromoles per literPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
Total bilirubin, Day 2,n=12,6,5,9,9,6-0.8 ± 3.86-1.3 ± 3.27-1.6 ± 4.34-0.2 ± 3.230.0 ± 5.201.0 ± 3.03
Total bilirubin, Day 3,n=12,6,6,9,9,6-1.3 ± 3.45-1.7 ± 3.44-1.7 ± 4.970.2 ± 3.80-0.4 ± 4.770.3 ± 2.34
Total bilirubin, Day 4,n=12,6,6,9,9,6-1.0 ± 3.13-2.7 ± 5.01-2.0 ± 7.480.0 ± 4.470.0 ± 4.471.0 ± 3.29
Total bilirubin, Day 5,n=12,6,6,9,9,6-2.3 ± 4.58-5.0 ± 5.76-2.0 ± 3.58-0.9 ± 5.49-1.3 ± 2.45-0.7 ± 3.27
Total bilirubin, Week 1,n=11,6,6,9,9,5-1.5 ± 4.82-0.7 ± 4.501.7 ± 1.97-1.1 ± 4.910.4 ± 3.84-2.0 ± 2.83
Total bilirubin, Week 2,n=12,6,6,9,9,6-1.2 ± 3.46-2.3 ± 6.120.7 ± 2.732.2 ± 2.910.4 ± 5.550.7 ± 2.42
Total bilirubin, Week 4,n=12,6,6,9,9,6-0.7 ± 2.150.3 ± 2.340.3 ± 1.970.0 ± 2.45-0.4 ± 5.811.0 ± 2.76
Total bilirubin, Week 8,n=12,6,6,9,9,6-1.2 ± 4.04-1.0 ± 6.292.0 ± 2.832.2 ± 4.060.4 ± 5.46-1.0 ± 4.69
Total bilirubin, Week 12,n=12,6,6,9,9,6-1.3 ± 4.030.0 ± 2.194.3 ± 5.85-0.9 ± 2.030.0 ± 4.69-0.7 ± 4.50
Total bilirubin, Week 18,n=12,6,6,9,9,6-0.3 ± 3.70-1.3 ± 6.532.0 ± 2.830.7 ± 1.730.4 ± 6.23-1.0 ± 3.52
Total bilirubin, Week 24,n=12,6,6,9,9,6-0.8 ± 4.47-1.3 ± 3.271.7 ± 3.880.2 ± 2.541.6 ± 6.982.0 ± 4.56
Total bilirubin, Week 26,n=12,6,6,9,9,6-1.3 ± 4.702.7 ± 3.930.3 ± 3.88-0.2 ± 3.80-0.7 ± 4.121.7 ± 2.34
Total bilirubin, Week 32,n=6,6,6,0,0,60.7 ± 2.07-1.0 ± 5.620.0 ± 5.22——0.0 ± 4.90
Total bilirubin, Week 36,n=6,0,0,9,9,0-0.7 ± 7.12——0.4 ± 3.13-1.1 ± 5.67—
Total bilirubin, Week 40,n=2,0,0,0,0,62.0 ± 0.00————0.7 ± 2.07
Direct bilirubin, Day 2,n=12,6,5,9,9,6-0.3 ± 1.15-0.7 ± 1.03-0.4 ± 0.89-0.2 ± 1.200.2 ± 1.200.3 ± 0.82
Direct bilirubin, Day 3,n=12,6,6,9,9,6-0.5 ± 0.90-0.3 ± 0.82-0.3 ± 0.820.4 ± 1.670.0 ± 1.000.0 ± 1.26
Direct bilirubin, Day 4,n=12,6,6,9,9,6-0.5 ± 0.90-0.3 ± 0.82-0.7 ± 1.030.2 ± 1.560.2 ± 1.20-0.3 ± 0.82
Direct bilirubin, Day 5,n=12,6,6,9,9,6-0.7 ± 0.98-0.7 ± 1.03-0.7 ± 1.030.2 ± 1.560.0 ± 1.00-0.7 ± 1.03
Direct bilirubin, Week 1,n=11,6,6,9,9,5-0.5 ± 0.93-0.3 ± 0.82-0.3 ± 0.820.0 ± 1.410.0 ± 1.00-0.8 ± 1.10
Direct bilirubin, Week 2,n=12,6,6,9,9,6-0.3 ± 1.150.0 ± 0.000.0 ± 0.000.7 ± 1.410.2 ± 1.200.3 ± 1.51
Direct bilirubin, Week 4,n=12,6,6,9,9,60.0 ± 0.850.0 ± 1.260.3 ± 0.820.2 ± 1.200.2 ± 1.200.0 ± 1.26
Direct bilirubin, Week 8,n=12,6,6,9,9,6-0.2 ± 1.030.0 ± 0.000.3 ± 0.820.9 ± 1.450.4 ± 1.33-0.7 ± 1.03
Direct bilirubin, Week 12,n=12,6,6,9,9,6-0.5 ± 0.900.0 ± 1.260.3 ± 0.820.2 ± 1.200.2 ± 1.20-0.3 ± 1.51
Direct bilirubin, Week 18,n=12,6,6,9,9,6-0.2 ± 1.030.0 ± 1.260.0 ± 0.000.7 ± 1.000.4 ± 1.330.0 ± 1.26
Direct bilirubin, Week 24,n=12,6,6,9,9,6-0.3 ± 0.780.3 ± 1.51-0.3 ± 0.820.2 ± 1.200.9 ± 1.760.0 ± 1.26
Direct bilirubin, Week 26,n=12,6,6,9,9,60.0 ± 1.210.7 ± 1.030.3 ± 0.820.0 ± 1.410.0 ± 1.000.0 ± 1.26
Direct bilirubin, Week 32,n=6,6,6,0,0,6-0.3 ± 0.82-0.3 ± 0.82-0.3 ± 1.51——0.0 ± 1.26
Direct bilirubin, Week 36,n=6,0,0,9,9,00.0 ± 1.79——0.0 ± 1.000.4 ± 1.67—
Direct bilirubin, Week 40,n=2,0,0,0,0,6-1.0 ± 1.41————-0.3 ± 0.82
Creatinine, Day 2,n=12,6,5,9,9,6-2.80 ± 5.501-1.03 ± 3.930-1.42 ± 3.512-4.91 ± 4.835-0.77 ± 4.863-1.63 ± 6.417
Creatinine, Day 3,n=12,6,6,9,9,6-3.48 ± 6.036-1.78 ± 3.571-2.95 ± 6.208-1.58 ± 4.913-1.87 ± 5.026-1.20 ± 3.795
Creatinine, Day 4,n=12,6,6,9,9,60.29 ± 6.544-0.73 ± 4.126-0.75 ± 7.123-4.64 ± 6.296-0.88 ± 3.1803.68 ± 7.962
Creatinine, Day 5,n=12,6,6,9,9,6-2.73 ± 5.1660.72 ± 1.883-2.53 ± 4.541-4.63 ± 6.3550.39 ± 3.085-1.62 ± 5.216
Creatinine, Week 1,n=11,6,6,9,9,5-2.49 ± 7.0843.68 ± 4.892-2.08 ± 6.098-3.06 ± 6.3930.59 ± 4.303-0.70 ± 7.736
Creatinine, Week 2,n=12,6,6,9,9,6-1.12 ± 5.8541.47 ± 5.019-0.90 ± 6.377-2.67 ± 5.7022.27 ± 5.3220.73 ± 7.868
Creatinine, Week 4,n=12,6,6,9,9,6-1.28 ± 4.730-2.80 ± 3.8390.27 ± 3.8370.09 ± 6.8430.59 ± 5.9896.05 ± 6.066
Creatinine, Week 8,n=12,6,6,9,9,6-1.40 ± 6.4620.28 ± 5.062-1.20 ± 7.2770.19 ± 3.7186.00 ± 4.5111.63 ± 4.317
Creatinine, Week 12,n=12,6,6,9,9,6-0.30 ± 7.6430.88 ± 5.0431.03 ± 5.846-0.41 ± 4.7485.01 ± 3.8200.72 ± 4.532
Creatinine, Week 18,n=12,6,6,9,9,6-1.27 ± 7.7531.75 ± 4.8312.05 ± 7.1312.83 ± 5.0334.42 ± 5.1911.15 ± 6.297
Creatinine, Week 24,n=12,6,6,9,9,60.89 ± 4.3931.77 ± 5.5971.60 ± 5.8777.07 ± 6.5812.66 ± 6.0052.20 ± 4.431
Creatinine, Week 26,n=12,6,6,9,9,6-2.29 ± 5.633-2.22 ± 5.0170.27 ± 15.3423.16 ± 6.6200.69 ± 3.8573.22 ± 5.653
Creatinine, Week 32,n=6,6,6,0,0,60.00 ± 5.8710.87 ± 5.9046.60 ± 6.880——2.05 ± 2.474
Creatinine, Week 36,n=6,0,0,9,9,0-0.60 ± 4.767——2.57 ± 4.34710.42 ± 6.864—
Creatinine, Week 40,n=2,0,0,0,0,61.75 ± 2.475————1.60 ± 6.174
PrimaryUrine Specific Gravity Analysis by Dipstick Method

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity.

Time frame:
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Reported as:
Mean · Ratio
Urine Specific Gravity Analysis by Dipstick Method
RatioPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
Day 2,n=1,2,0,2,0,01.0200 ± NA1.0125 ± 0.00354—1.0120 ± 0.00283——
Day 3,n=2,0,0,1,0,01.0265 ± 0.00212——1.0280 ± NA——
Day 4,n=0,0,1,1,0,0——1.0150 ± NA1.0290 ± NA——
Day 5,n=2,0,0,2,1,01.0275 ± 0.00354——1.0205 ± 0.009191.0140 ± NA—
Week 1,n=2,1,1,3,0,01.0235 ± 0.002121.0260 ± NA1.0250 ± NA1.0197 ± 0.00751——
Week 2,n=1,0,0,4,1,01.0250 ± NA——1.0218 ± 0.008221.0130 ± NA—
Week 4,n=3,1,1,5,0,11.0193 ± 0.008391.0150 ± NA1.0250 ± NA1.0158 ± 0.01052—1.0270 ± NA
Week 8,n=1,0,0,2,0,01.0300 ± NA——1.0220 ± 0.00566——
Week 12,n=0,1,0,1,0,0—1.0180 ± NA—1.0230 ± NA——
Week 18,n=3,1,0,1,0,01.0260 ± 0.002651.0180 ± NA—1.0230 ± NA——
Week 24,n=1,1,0,4,0,01.0200 ± NA1.0230 ± NA—1.0200 ± 0.00374——
Week 26,n=0,0,0,2,0,0———1.0240 ± 0.00566——
Week 32,n=1,0,0,0,0,01.0150 ± NA—————
PrimaryChange From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

SBP and DBP were assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Reported as:
Mean · Millimeters of mercury
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Millimeters of mercuryPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
SBP, 2 hours Day1,n=12,6,6,9,9,6-0.3 ± 6.08-2.2 ± 7.473.3 ± 7.37-0.9 ± 7.18-1.8 ± 7.19-2.0 ± 8.58
SBP, 8 hours Day1,n=12,6,6,9,9,60.0 ± 6.004.2 ± 10.013.0 ± 8.461.7 ± 10.694.9 ± 7.52-2.2 ± 5.64
SBP, Day 2,n=12,6,6,9,9,6-2.5 ± 7.00-0.8 ± 8.086.0 ± 4.861.8 ± 9.116.3 ± 7.42-5.3 ± 4.37
SBP, Day 3,n=12,6,6,9,9,62.6 ± 9.21-2.2 ± 7.363.7 ± 9.161.0 ± 10.68-0.1 ± 4.43-5.0 ± 6.00
SBP, Day 4,n=12,6,6,9,9,60.8 ± 5.75-2.2 ± 6.242.3 ± 8.090.3 ± 6.912.9 ± 6.86-3.3 ± 7.39
SBP, Day 5,n=12,6,6,9,9,6-3.0 ± 6.050.8 ± 6.821.0 ± 7.72-2.8 ± 9.810.4 ± 3.91-4.7 ± 4.46
SBP, Week 1,n=12,6,6,9,9,6-0.3 ± 8.860.3 ± 7.501.5 ± 6.60-2.7 ± 9.061.7 ± 5.020.2 ± 8.13
SBP, Week 2,n=12,6,6,9,9,6-2.6 ± 5.901.0 ± 10.225.8 ± 5.854.2 ± 10.450.8 ± 11.04-2.8 ± 9.83
SBP, Week 4,n=12,6,6,9,9,6-1.6 ± 8.800.3 ± 8.827.0 ± 11.263.2 ± 14.090.9 ± 6.11-2.3 ± 7.15
SBP, Week 8,n=12,6,6,9,9,60.7 ± 9.710.0 ± 9.272.0 ± 12.663.1 ± 8.52-1.4 ± 6.60-1.8 ± 5.91
SBP, Week 12,n=12,6,6,9,9,6-0.8 ± 5.131.2 ± 5.192.3 ± 9.975.4 ± 9.410.0 ± 7.37-4.2 ± 11.18
SBP, Week 18,n=12,6,6,9,9,6-0.6 ± 6.864.2 ± 9.153.8 ± 13.332.0 ± 8.762.1 ± 9.52-7.3 ± 15.49
SBP, Week 24,n=12,6,6,9,9,6-0.8 ± 8.229.3 ± 10.423.7 ± 6.592.9 ± 9.911.9 ± 12.06-2.2 ± 6.46
SBP, Week 26,n=12,6,6,9,9,63.0 ± 11.953.2 ± 6.113.2 ± 5.917.9 ± 10.132.9 ± 7.56-5.8 ± 6.11
SBP, Week 32,n=6,6,6,0,0,63.0 ± 6.90-3.8 ± 12.458.7 ± 10.61——-3.3 ± 6.89
SBP, Week 36,n=6,0,0,9,9,0-3.5 ± 13.72——2.8 ± 9.592.8 ± 7.77—
SBP, Week 40,n=2,0,0,0,0,6-15.0 ± 14.14————-5.8 ± 17.52
DBP, 2 hours Day1,n=12,6,6,9,9,6-2.9 ± 5.003.3 ± 4.894.3 ± 9.14-2.2 ± 4.18-2.2 ± 6.14-3.8 ± 1.94
DBP, 8 hours Day1,n=12,6,6,9,9,6-0.6 ± 4.342.0 ± 7.460.5 ± 9.52-1.3 ± 4.58-2.0 ± 5.74-1.8 ± 5.56
DBP, Day 2,n=12,6,6,9,9,6-0.2 ± 4.470.8 ± 4.493.0 ± 5.83-1.1 ± 5.674.7 ± 4.180.0 ± 4.94
DBP, Day 3,n=12,6,6,9,9,60.6 ± 3.99-1.3 ± 7.263.0 ± 7.04-2.6 ± 5.41-0.3 ± 4.30-0.3 ± 6.44
DBP, Day 4,n=12,6,6,9,9,6-0.1 ± 5.042.3 ± 4.80-1.0 ± 5.69-0.2 ± 5.140.1 ± 3.76-2.8 ± 3.82
DBP, Day 5,n=12,6,6,9,9,6-1.4 ± 4.404.8 ± 6.490.7 ± 8.09-4.1 ± 7.290.9 ± 4.23-1.5 ± 2.81
DBP, Week 1,n=12,6,6,9,9,60.6 ± 5.373.7 ± 6.984.3 ± 9.27-0.4 ± 5.680.8 ± 3.380.0 ± 5.44
DBP, Week 2,n=12,6,6,9,9,61.1 ± 6.234.7 ± 5.656.0 ± 8.991.6 ± 4.361.9 ± 6.920.2 ± 4.62
DBP, Week 4,n=12,6,6,9,9,60.3 ± 6.171.3 ± 7.744.2 ± 11.363.1 ± 6.091.6 ± 5.413.8 ± 4.40
DBP, Week 8,n=12,6,6,9,9,61.3 ± 3.735.2 ± 5.495.5 ± 13.283.3 ± 4.950.7 ± 4.210.5 ± 3.94
DBP, Week 12,n=12,6,6,9,9,60.9 ± 6.293.2 ± 5.911.7 ± 14.153.4 ± 5.393.6 ± 4.721.3 ± 5.09
DBP, Week 18,n=12,6,6,9,9,6-2.1 ± 6.633.3 ± 5.683.0 ± 12.650.7 ± 6.843.8 ± 8.070.5 ± 7.50
DBP, Week 24,n=12,6,6,9,9,6-1.6 ± 7.776.3 ± 5.354.0 ± 9.785.3 ± 6.561.1 ± 9.122.0 ± 5.66
DBP, Week 26,n=12,6,6,9,9,6-0.5 ± 7.233.2 ± 4.363.8 ± 9.456.6 ± 8.381.8 ± 8.610.2 ± 3.97
DBP, Week 32,n=6,6,6,0,0,61.3 ± 2.34-0.2 ± 6.497.0 ± 4.34——2.0 ± 7.64
DBP, Week 36,n=6,0,0,9,9,02.3 ± 13.13——3.6 ± 5.642.3 ± 8.82—
DBP, Week 40,n=2,0,0,0,0,60.5 ± 4.95————-3.5 ± 6.95
PrimaryChange From Baseline in Temperature

Temperature was assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Reported as:
Mean · Degree Celsius
Change From Baseline in Temperature
Degree CelsiusPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
2 hours Day1,n=12,6,6,9,9,60.05 ± 0.4190.32 ± 0.2930.13 ± 0.1630.30 ± 0.4740.03 ± 0.3280.00 ± 0.420
Category title 2. 8 hours Day1,n=12,6,6,9,9,60.13 ± 0.4050.40 ± 0.4100.07 ± 0.2340.24 ± 0.5130.18 ± 0.2910.35 ± 0.589
Category title 3. Day 2,n=12,6,6,9,9,6-0.01 ± 0.3120.23 ± 0.4370.10 ± 0.429-0.03 ± 0.559-0.01 ± 0.333-0.05 ± 0.259
Day 3,n=12,6,6,9,9,6-0.10 ± 0.4020.02 ± 0.5380.02 ± 0.2560.13 ± 0.4390.02 ± 0.3150.12 ± 0.343
Day 4,n=12,6,6,9,9,6-0.03 ± 0.2600.15 ± 0.5540.08 ± 0.2930.11 ± 0.3820.22 ± 0.2390.02 ± 0.397
Day 5,n=12,6,6,9,9,6-0.08 ± 0.1710.13 ± 0.5160.25 ± 0.464-0.07 ± 0.300-0.04 ± 0.2550.12 ± 0.293
Week 1,n=12,6,6,9,9,6-0.13 ± 0.2930.32 ± 0.4920.18 ± 0.1470.12 ± 0.3990.01 ± 0.3590.18 ± 0.232
Week 2,n=12,6,6,9,9,6-0.29 ± 0.4480.30 ± 0.4600.03 ± 0.3330.04 ± 0.3400.08 ± 0.441-0.08 ± 0.319
Week 4,n=12,6,6,9,9,6-0.23 ± 0.1720.20 ± 0.400-0.02 ± 0.387-0.09 ± 0.3020.00 ± 0.671-0.03 ± 0.258
Week 8,n=12,6,6,9,9,60.00 ± 0.2800.32 ± 0.397-0.18 ± 0.5040.09 ± 0.4460.02 ± 0.2820.13 ± 0.197
Week 12,n=12,6,6,9,9,6-0.10 ± 0.3860.17 ± 0.356-0.15 ± 0.1870.09 ± 0.337-0.09 ± 0.3550.00 ± 0.369
Week 18,n=12,6,6,9,9,6-0.07 ± 0.2670.18 ± 0.6620.02 ± 0.4070.13 ± 0.5120.07 ± 0.283-0.05 ± 0.399
Week 24,n=12,6,6,9,9,6-0.07 ± 0.3960.08 ± 0.4880.08 ± 0.319-0.02 ± 0.367-0.07 ± 0.316-0.02 ± 0.133
Week 26,n=12,6,6,9,9,6-0.08 ± 0.3110.03 ± 0.441-0.02 ± 0.5040.08 ± 0.4240.00 ± 0.442-0.22 ± 0.117
Week 32,n=6,6,6,0,0,6-0.30 ± 0.5690.48 ± 1.3630.02 ± 0.306——0.08 ± 0.331
Week 36,n=6,0,0,9,9,00.22 ± 0.366——0.14 ± 0.433-0.03 ± 0.212—
Week 40,n=2,0,0,0,0,6-0.10 ± 0.566————-0.05 ± 0.084
PrimaryChange From Baseline in Heart Rate

Heart rate was assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Reported as:
Mean · Beats per minute
Change From Baseline in Heart Rate
Beats per minutePlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
2 hours Day1,n=12,6,6,9,9,62.2 ± 13.62-4.2 ± 5.27-3.3 ± 8.640.8 ± 14.450.9 ± 10.745.2 ± 5.46
8 hours Day1,n=12,6,6,9,9,6-1.0 ± 7.05-2.0 ± 7.27-3.2 ± 3.370.3 ± 14.211.0 ± 11.624.8 ± 8.06
Day 2,n=12,6,6,9,9,6-1.2 ± 6.59-1.5 ± 2.81-1.7 ± 3.83-4.0 ± 11.032.7 ± 8.14-0.7 ± 3.50
Day 3,n=12,6,6,9,9,6-0.2 ± 4.820.2 ± 5.881.3 ± 8.410.7 ± 4.924.7 ± 3.94-1.0 ± 7.40
Day 4,n=12,6,6,9,9,63.8 ± 7.531.7 ± 4.844.7 ± 8.98-1.2 ± 11.623.6 ± 5.271.5 ± 3.33
Day 5,n=12,6,6,9,9,61.1 ± 4.912.8 ± 8.611.2 ± 7.83-0.1 ± 10.300.6 ± 4.283.0 ± 4.47
Week 1,n=12,6,6,9,9,6-1.8 ± 6.030.0 ± 10.58-1.8 ± 7.05-1.1 ± 10.801.4 ± 5.985.0 ± 9.21
Week 2,n=12,6,6,9,9,6-4.8 ± 5.57-1.3 ± 5.89-5.2 ± 5.232.1 ± 12.381.0 ± 10.512.0 ± 6.00
Week 4,n=12,6,6,9,9,6-3.2 ± 8.46-2.3 ± 2.88-1.5 ± 5.96-1.1 ± 10.540.8 ± 13.580.5 ± 9.35
Week 8,n=12,6,6,9,9,6-0.2 ± 7.12-1.8 ± 7.14-3.7 ± 5.79-4.9 ± 15.39-0.6 ± 6.52-0.3 ± 4.72
Week 12,n=12,6,6,9,9,6-1.2 ± 10.473.3 ± 8.38-2.3 ± 6.530.6 ± 16.411.0 ± 9.313.0 ± 7.38
Week 18,n=12,6,6,9,9,6-3.2 ± 8.56-2.0 ± 7.07-1.7 ± 5.500.8 ± 10.841.7 ± 9.102.5 ± 7.23
Week 24,n=12,6,6,9,9,6-1.4 ± 10.03-0.8 ± 6.851.8 ± 7.68-2.8 ± 12.043.2 ± 9.280.0 ± 4.82
Week 26,n=12,6,6,9,9,6-2.7 ± 10.04-0.2 ± 2.56-0.7 ± 6.592.0 ± 12.031.6 ± 7.091.8 ± 4.58
Week 32,n=6,6,6,0,0,6-1.0 ± 10.55-2.2 ± 5.190.7 ± 6.06——0.8 ± 7.28
Week 36,n=6,0,0,9,9,00.5 ± 11.59——0.0 ± 12.502.6 ± 6.29—
Week 40,n=2,0,0,0,0,6-2.0 ± 2.83————2.8 ± 10.26
PrimaryChange From Baseline in Respiration Rate

Respiration rate was assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Reported as:
Mean · Breaths per minute
Change From Baseline in Respiration Rate
Breaths per minutePlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
2 hours Day1,n=12,6,6,9,9,60.8 ± 2.421.2 ± 1.830.0 ± 2.530.3 ± 2.650.8 ± 1.722.2 ± 3.31
8 hours Day1,n=12,6,6,9,9,6-0.1 ± 2.190.5 ± 3.27-1.0 ± 1.791.0 ± 3.282.1 ± 1.830.3 ± 1.63
Day 2,n=12,6,6,9,9,6-0.7 ± 2.641.7 ± 2.58-1.2 ± 1.471.9 ± 1.961.8 ± 1.301.5 ± 2.07
Day 3,n=12,6,6,9,9,6-1.0 ± 2.831.5 ± 3.27-0.2 ± 2.401.1 ± 2.801.2 ± 2.110.7 ± 3.50
Day 4,n=12,6,6,9,9,6-0.1 ± 3.06-1.0 ± 3.030.7 ± 1.210.3 ± 2.242.3 ± 1.870.2 ± 2.71
Day 5,n=12,6,6,9,9,6-1.1 ± 2.390.7 ± 3.20-1.5 ± 1.050.0 ± 2.551.3 ± 2.180.0 ± 1.41
Week 1,n=12,6,6,9,9,6-0.5 ± 3.450.7 ± 3.67-0.2 ± 1.33-0.6 ± 1.670.4 ± 1.81-1.8 ± 2.71
Week 2,n=12,6,6,9,9,6-0.3 ± 2.150.7 ± 4.080.2 ± 2.231.1 ± 2.760.9 ± 2.98-0.2 ± 3.06
Week 4,n=12,6,6,9,9,60.5 ± 3.181.5 ± 2.591.5 ± 1.220.4 ± 1.881.2 ± 2.17-0.5 ± 3.89
Week 8,n=12,6,6,9,9,6-0.5 ± 2.710.5 ± 2.810.3 ± 2.420.1 ± 3.412.3 ± 2.180.7 ± 2.80
Week 12,n=12,6,6,9,9,60.0 ± 3.490.7 ± 4.630.7 ± 2.161.2 ± 2.860.9 ± 1.69-0.3 ± 2.88
Week 18,n=12,6,6,9,9,60.5 ± 3.66-0.2 ± 3.06-0.7 ± 1.971.4 ± 2.071.4 ± 1.421.2 ± 3.25
Week 24,n=12,6,6,9,9,6-0.8 ± 2.59-0.7 ± 4.41-0.7 ± 1.511.4 ± 2.130.7 ± 2.400.8 ± 1.94
Week 26,n=12,6,6,9,9,6-1.1 ± 2.430.5 ± 3.02-0.7 ± 1.510.6 ± 2.011.6 ± 2.190.3 ± 3.01
Week 32,n=6,6,6,0,0,6-1.5 ± 1.761.3 ± 3.010.7 ± 2.34——1.0 ± 3.10
Week 36,n=6,0,0,9,9,00.2 ± 1.83——0.2 ± 2.641.3 ± 1.50—
Week 40,n=2,0,0,0,0,6-2.0 ± 1.41————-0.3 ± 1.86
PrimaryChange From Baseline in Heart Rate: Electrocardiogram (ECG)

12-lead ECG were performed in a supine position using an automated ECG machine that calculated the heart rate and measured PR, QRS, QT and corrected QT (QTc) intervals. ECG measurements were performed in triplicate. When multiple ECGs were performed at the same planned timepoint, the average value of each parameter was used. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at 2 and 8 hours on Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Reported as:
Mean · Beats per minute
Change From Baseline in Heart Rate: Electrocardiogram (ECG)
Beats per minutePlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
2 hours Day1,n=12,6,5,9,8,61.4 ± 11.13-4.3 ± 7.81-4.6 ± 4.560.2 ± 11.060.3 ± 11.856.8 ± 7.01
8 hours Day1,n=12,6,6,9,9,60.1 ± 6.34-0.8 ± 8.93-6.3 ± 6.10-1.3 ± 6.230.0 ± 14.054.1 ± 6.20
Day 2,n=12,6,6,9,9,60.4 ± 4.68-0.4 ± 5.670.8 ± 5.29-1.4 ± 6.32-0.3 ± 7.340.3 ± 1.06
Day 3,n=12,6,6,9,9,61.5 ± 5.930.3 ± 4.150.4 ± 7.361.5 ± 7.033.1 ± 3.481.9 ± 3.69
Day 4,n=12,6,6,9,9,63.5 ± 5.111.5 ± 8.645.5 ± 9.133.1 ± 11.042.6 ± 4.603.2 ± 3.97
Day 5,n=12,6,6,9,9,61.8 ± 4.781.5 ± 9.630.8 ± 5.242.5 ± 5.29-0.4 ± 5.972.6 ± 4.75
Week 1,n=12,6,6,9,9,6-2.8 ± 5.741.6 ± 5.76-2.4 ± 5.532.4 ± 9.662.0 ± 4.764.9 ± 7.60
Week 2,n=12,6,6,9,9,6-4.2 ± 5.32-2.3 ± 5.02-5.9 ± 5.911.8 ± 10.261.7 ± 13.561.7 ± 7.11
Week 4,n=12,6,6,9,9,6-3.8 ± 7.01-1.6 ± 3.75-1.2 ± 3.45-1.6 ± 7.53-0.3 ± 14.55-0.9 ± 6.25
Week 8,n=12,6,6,9,9,6-0.8 ± 5.91-0.6 ± 6.22-2.0 ± 6.02-2.9 ± 7.50-0.7 ± 9.140.6 ± 4.97
Week 12,n=12,6,6,9,9,60.3 ± 11.83-1.3 ± 6.24-3.3 ± 6.351.8 ± 15.280.4 ± 11.551.3 ± 6.44
Week 18,n=12,6,6,9,9,6-3.4 ± 9.05-0.4 ± 6.59-3.3 ± 5.201.6 ± 6.920.6 ± 8.782.2 ± 4.65
Week 24,n=12,6,6,9,9,6-2.7 ± 7.95-0.2 ± 8.282.5 ± 8.00-0.3 ± 9.131.7 ± 11.031.2 ± 6.47
Week 26,n=12,6,6,9,9,6-2.0 ± 9.35-0.3 ± 5.16-1.5 ± 7.182.5 ± 11.972.0 ± 8.220.3 ± 7.66
Week 32,n=6,6,6,0,0,6-2.7 ± 9.21-4.6 ± 7.340.7 ± 5.84——2.3 ± 6.46
Week 36,n=6,0,0,9,9,01.5 ± 7.13——-0.2 ± 10.261.3 ± 5.74—
Week 40,n=2,0,0,0,0,6-4.3 ± 0.47————3.6 ± 9.08
PrimaryChange From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval

12-lead ECG were performed in a supine position using an automated ECG machine that calculated PR interval, QRS interval, QT interval and QTcF interval. ECG measurements were performed in triplicate. When multiple ECGs were performed at the same planned timepoint, the average value of each parameter was used. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at 2 and 8 hours on Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Reported as:
Mean · Milliseconds
Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
MillisecondsPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
PR Interval,2 hours Day1,n=12,6,5,9,8,6-4.5 ± 9.463.9 ± 2.853.5 ± 8.47-4.3 ± 9.103.7 ± 1.075-7.5 ± 12.23
PR Interval,8 hours Day1,n=12,6,6,9,9,6-4.1 ± 8.493.1 ± 6.02-1.8 ± 3.72-4.5 ± 11.761.9 ± 11.39-3.3 ± 10.88
PR Interval,Day 2,n=12,6,6,9,9,6-2.7 ± 11.512.0 ± 4.111.4 ± 3.95-4.4 ± 9.866.2 ± 11.05-4.1 ± 11.25
PR Interval, Day 3,n=12,6,6,9,9,62.3 ± 6.685.2 ± 4.290.5 ± 5.62-3.6 ± 11.966.0 ± 7.60-1.4 ± 8.82
PR Interval,Day 4,n=12,6,6,9,9,6-0.6 ± 6.808.1 ± 5.21-2.5 ± 6.12-2.3 ± 8.888.6 ± 10.17-4.3 ± 7.54
PR Interval,Day 5,n=12,6,6,9,9,61.3 ± 6.228.3 ± 8.223.5 ± 10.05-0.2 ± 4.5410.0 ± 8.44-1.2 ± 4.91
PR Interval,Week 1,n=12,6,6,9,9,6-0.3 ± 8.120.8 ± 5.582.2 ± 5.69-3.2 ± 12.267.0 ± 6.624.5 ± 6.73
PR Interval,Week 2,n=12,6,6,9,9,6-1.0 ± 8.625.3 ± 6.605.5 ± 10.341.8 ± 12.192.0 ± 12.641.0 ± 2.97
PR Interval,Week 4,n=12,6,6,8,9,61.7 ± 10.275.2 ± 3.371.8 ± 12.71-1.8 ± 15.253.9 ± 11.28-4.0 ± 17.49
PR Interval,Week 8,n=12,6,6,9,9,6-3.1 ± 8.273.2 ± 9.65-2.6 ± 10.27-3.6 ± 10.333.4 ± 8.10-1.9 ± 9.55
PR Interval,Week 12,n=12,6,6,9,9,6-2.4 ± 7.873.9 ± 10.53-4.4 ± 12.18-3.8 ± 13.269.4 ± 8.33-2.1 ± 10.04
PR Interval,Week 18,n=12,6,6,9,9,61.5 ± 10.741.5 ± 3.990.1 ± 7.74-5.6 ± 11.877.3 ± 13.34-2.0 ± 9.72
PR Interval,Week 24,n=12,6,6,9,9,62.3 ± 7.981.4 ± 3.913.7 ± 7.25-7.4 ± 11.565.5 ± 12.45-5.6 ± 7.87
PR Interval,Week 26,n=12,6,6,9,9,61.1 ± 6.203.0 ± 4.673.7 ± 11.62-3.2 ± 13.016.9 ± 11.36-4.8 ± 11.69
PR Interval,Week 32,n=6,6,6,0,0,6-4.3 ± 8.165.4 ± 7.230.0 ± 7.99——-3.3 ± 11.91
PR Interval,Week 36,n=6,0,0,9,9,0-0.5 ± 8.26——-3.7 ± 8.492.9 ± 12.08—
PR Interval,Week 40,n=2,0,0,0,0,6-13.7 ± 6.60————-3.6 ± 8.56
QRS Interval,2 hours Day1,n=12,6,5,9,8,61.1 ± 4.870.2 ± 4.63-7.2 ± 4.970.0 ± 4.43-1.5 ± 6.14-1.2 ± 3.62
QRS Interval,8 hours Day1,n=12,6,6,9,9,6-0.3 ± 6.83-0.2 ± 6.81-4.0 ± 6.18-1.1 ± 3.18-2.8 ± 5.03-3.1 ± 4.42
QRS Interval,Day 2,n=12,6,6,9,9,61.8 ± 4.640.5 ± 4.63-4.9 ± 4.60-2.7 ± 5.28-3.0 ± 6.27-3.7 ± 4.62
QRS Interval, Day 3,n=12,6,6,9,9,61.4 ± 3.441.4 ± 4.18-1.3 ± 3.14-0.6 ± 4.03-2.6 ± 5.15-2.6 ± 1.54
QRS Interval,Day 4,n=12,6,6,9,9,60.4 ± 3.781.9 ± 3.72-7.8 ± 5.521.1 ± 5.28-0.7 ± 5.24-2.2 ± 3.38
QRS Interval,Day 5,n=12,6,6,9,9,6-0.5 ± 4.050.2 ± 5.85-7.3 ± 4.79-0.2 ± 5.400.7 ± 5.09-2.9 ± 2.35
QRS Interval,Week 1,n=12,6,6,9,9,62.3 ± 5.050.6 ± 5.85-3.7 ± 6.180.6 ± 4.90-2.4 ± 5.61-2.8 ± 4.20
QRS Interval,Week 2,n=12,6,6,9,9,62.1 ± 3.762.1 ± 4.82-3.9 ± 4.760.9 ± 2.86-3.0 ± 5.47-1.4 ± 3.11
QRS Interval,Week 4,n=12,6,6,8,9,62.0 ± 6.491.8 ± 7.34-6.5 ± 7.761.9 ± 4.79-2.6 ± 4.98-3.3 ± 3.39
QRS Interval,Week 8,n=12,6,6,9,9,61.9 ± 7.27-1.0 ± 4.35-3.6 ± 5.230.9 ± 4.120.5 ± 5.71-1.9 ± 1.83
QRS Interval,Week 12,n=12,6,6,9,9,61.6 ± 4.203.1 ± 3.28-4.4 ± 6.04-0.1 ± 5.23-2.5 ± 3.11-1.1 ± 3.21
QRS Interval,Week 18,n=12,6,6,9,9,60.6 ± 3.901.8 ± 2.79-5.0 ± 5.430.4 ± 3.16-2.9 ± 4.53-1.6 ± 4.17
QRS Interval,Week 24,n=12,6,6,9,9,60.6 ± 5.941.8 ± 6.53-6.5 ± 5.56-1.1 ± 3.76-3.1 ± 2.01-1.8 ± 5.12
QRS Interval,Week 26,n=12,6,6,9,9,60.0 ± 4.612.1 ± 4.64-5.5 ± 5.750.4 ± 5.55-2.7 ± 6.570.4 ± 3.40
QRS Interval,Week 32,n=6,6,6,0,0,62.9 ± 5.782.0 ± 5.17-6.1 ± 4.50——-1.3 ± 2.56
QRS Interval,Week 36,n=6,0,0,9,9,0-3.7 ± 6.19——0.7 ± 5.14-3.9 ± 4.84—
QRS Interval,Week 40,n=2,0,0,0,0,60.0 ± 0.47————-3.0 ± 3.47
QT Interval,2 hours Day1,n=12,6,5,9,8,6-2.6 ± 22.5514.8 ± 16.656.0 ± 11.28-2.9 ± 20.19-3.7 ± 23.95-9.2 ± 18.68
QT Interval,8 hours Day1,n=12,6,6,9,9,6-7.5 ± 16.466.7 ± 16.2212.6 ± 18.531.5 ± 14.29-0.7 ± 29.93-7.6 ± 22.43
QT Interval,Day 2,n=12,6,6,9,9,6-4.9 ± 19.324.3 ± 14.01-14.1 ± 16.26-3.0 ± 18.80-6.1 ± 15.86-0.6 ± 11.09
QT Interval, Day 3,n=12,6,6,9,9,6-10.1 ± 19.82-0.9 ± 10.33-6.9 ± 14.95-7.6 ± 18.49-13.2 ± 15.20-2.4 ± 9.29
QT Interval,Day 4,n=12,6,6,9,9,6-12.3 ± 17.15-2.2 ± 14.32-15.9 ± 21.55-11.6 ± 25.81-10.9 ± 11.99-3.2 ± 17.05
QT Interval,Day 5,n=12,6,6,9,9,6-5.9 ± 14.18-2.2 ± 21.88-14.3 ± 13.83-9.5 ± 14.97-4.1 ± 18.72-1.3 ± 11.57
QT Interval,Week 1,n=12,6,6,9,9,65.3 ± 17.308.7 ± 14.190.0 ± 21.14-9.4 ± 19.82-1.0 ± 22.22-5.6 ± 23.13
QT Interval,Week 2,n=12,6,6,9,9,69.4 ± 16.2312.9 ± 8.147.8 ± 17.651.0 ± 22.66-6.1 ± 17.108.3 ± 20.06
QT Interval,Week 4,n=12,6,6,8,9,69.4 ± 20.4311.0 ± 4.78-3.6 ± 24.503.3 ± 17.801.7 ± 34.5214.0 ± 18.29
QT Interval,Week 8,n=12,6,6,9,9,6-0.6 ± 20.746.9 ± 9.281.0 ± 23.624.6 ± 19.06-2.0 ± 20.796.0 ± 15.76
QT Interval,Week 12,n=12,6,6,9,9,6-6.8 ± 20.648.1 ± 16.214.2 ± 22.53-6.5 ± 28.72-2.1 ± 26.691.1 ± 14.24
QT Interval,Week 18,n=12,6,6,9,9,67.3 ± 22.446.3 ± 15.00-2.8 ± 15.12-4.5 ± 19.10-6.7 ± 23.770.5 ± 12.14
QT Interval,Week 24,n=12,6,6,9,9,67.1 ± 23.224.2 ± 18.11-9.9 ± 27.450.7 ± 19.24-8.6 ± 19.007.9 ± 23.80
QT Interval,Week 26,n=12,6,6,9,9,62.3 ± 27.3610.2 ± 12.920.9 ± 29.72-6.1 ± 22.91-9.8 ± 18.2913.2 ± 20.96
QT Interval,Week 32,n=6,6,6,0,0,65.7 ± 20.3212.9 ± 12.12-14.4 ± 17.64——5.3 ± 14.64
QT Interval,Week 36,n=6,0,0,9,9,0-6.4 ± 41.25——-3.4 ± 29.83-9.3 ± 16.00—
QT Interval,Week 40,n=2,0,0,0,0,623.5 ± 17.68————-0.9 ± 24.13
QTcF Interval,2 hours Day1,n=12,6,5,9,8,6-0.6 ± 9.114.1 ± 8.67-5.5 ± 8.11-3.4 ± 6.40-2.3 ± 5.386.4 ± 5.17
QTcF Interval,8 hours Day1,n=12,6,6,9,9,6-6.8 ± 12.974.3 ± 7.93-3.6 ± 12.32-1.4 ± 9.87-0.4 ± 8.322.1 ± 13.97
QTcF Interval,Day 2,n=12,6,6,9,9,6-4.0 ± 11.782.6 ± 8.43-12.8 ± 10.87-6.9 ± 9.34-5.9 ± 5.70-0.2 ± 10.66
QTcF Interval, Day 3,n=12,6,6,9,9,6-6.8 ± 14.990.4 ± 5.82-6.5 ± 9.14-5.3 ± 9.95-6.3 ± 10.711.9 ± 14.28
QTcF Interval,Day 4,n=12,6,6,9,9,6-4.9 ± 14.080.7 ± 7.62-6.1 ± 7.10-7.7 ± 12.56-4.8 ± 10.753.5 ± 17.05
QTcF Interval,Day 5,n=12,6,6,9,9,6-1.7 ± 11.971.5 ± 14.24-13.6 ± 11.17-4.7 ± 9.86-4.4 ± 14.313.9 ± 16.06
QTcF Interval,Week 1,n=12,6,6,9,9,6-0.2 ± 10.9510.3 ± 7.33-6.7 ± 12.72-5.4 ± 8.382.8 ± 12.125.5 ± 13.80
QTcF Interval,Week 2,n=12,6,6,9,9,60.9 ± 16.406.3 ± 6.98-8.3 ± 8.213.7 ± 19.35-2.3 ± 12.6411.5 ± 12.63
QTcF Interval,Week 4,n=12,6,6,8,9,6-0.6 ± 11.227.3 ± 7.10-6.6 ± 20.630.5 ± 10.86-0.7 ± 10.9711.4 ± 6.33
QTcF Interval,Week 8,n=12,6,6,9,9,6-2.8 ± 13.765.2 ± 9.28-4.8 ± 14.70-1.7 ± 11.96-2.9 ± 14.108.1 ± 20.96
QTcF Interval,Week 12,n=12,6,6,9,9,6-6.4 ± 14.395.9 ± 13.50-5.3 ± 10.66-5.9 ± 10.93-1.1 ± 11.914.7 ± 10.23
QTcF Interval,Week 18,n=12,6,6,9,9,6-0.5 ± 11.734.8 ± 6.79-10.4 ± 9.42-0.6 ± 12.29-5.2 ± 12.815.9 ± 11.16
QTcF Interval,Week 24,n=12,6,6,9,9,61.4 ± 15.423.0 ± 10.83-7.2 ± 12.140.4 ± 7.96-3.9 ± 12.6910.1 ± 15.15
QTcF Interval,Week 26,n=12,6,6,9,9,6-1.9 ± 16.589.6 ± 9.37-3.9 ± 14.54-1.7 ± 10.65-4.4 ± 12.2112.8 ± 8.59
QTcF Interval,Week 32,n=6,6,6,0,0,60.4 ± 10.981.3 ± 7.93-13.8 ± 8.76——11.7 ± 13.74
QTcF Interval,Week 36,n=6,0,0,9,9,0-3.7 ± 24.89——-4.3 ± 13.45-5.5 ± 14.23—
QTcF Interval,Week 40,n=2,0,0,0,0,612.0 ± 17.44————7.5 ± 14.62
SecondaryArea Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK3511294 2 mg and 10 mg

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-inf). Pharmacokinetic parameters were calculated by standard non compartmental analysis. Pharmacokinetic Population included participants in the Safety population for whom a pharmcokinetic sample was obtained and analyzed.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose
Reported as:
Geometric mean · Day*microgram per milliliter
Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK3511294 2 mg and 10 mg
Day*microgram per milliliterGSK3511294 2mgGSK3511294 10mg
Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK3511294 2 mg and 10 mg24.795 ± 51.668.904 ± 23.6
SecondaryAUC(0-inf) of GSK3511294 30 mg and 100 mg

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-inf). Pharmacokinetic parameters were calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose
Reported as:
Geometric mean · Day*microgram per milliliter
AUC(0-inf) of GSK3511294 30 mg and 100 mg
Day*microgram per milliliterGSK3511294 30mgGSK3511294 100mg
AUC(0-inf) of GSK3511294 30 mg and 100 mg208.308 ± 39.6846.686 ± 7.3
SecondaryAUC(0-inf) of GSK3511294 300 mg

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-inf). Pharmacokinetic parameters were calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose
Reported as:
Geometric mean · Day*microgram per milliliter
AUC(0-inf) of GSK3511294 300 mg
Day*microgram per milliliterGSK3511294 300mg
AUC(0-inf) of GSK3511294 300 mg1873.657 ± 25.5
SecondaryArea Under the Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of GSK3511294 2 mg and 10 mg

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). Pharmacokinetic parameters were calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose
Reported as:
Geometric mean · Day*microgram per milliliter
Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of GSK3511294 2 mg and 10 mg
Day*microgram per milliliterGSK3511294 2mgGSK3511294 10mg
Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of GSK3511294 2 mg and 10 mg18.369 ± 59.262.101 ± 28.4
SecondaryAUC(0-t) of GSK3511294 30 mg and 100 mg

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). Pharmacokinetic parameters were calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose
Reported as:
Geometric mean · Day*microgram per milliliter
AUC(0-t) of GSK3511294 30 mg and 100 mg
Day*microgram per milliliterGSK3511294 30mgGSK3511294 100mg
AUC(0-t) of GSK3511294 30 mg and 100 mg201.434 ± 41.1830.245 ± 7.4
SecondaryAUC(0-t) of GSK3511294 300 mg

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose
Reported as:
Geometric mean · Day*microgram per milliliter
AUC(0-t) of GSK3511294 300 mg
Day*microgram per milliliterGSK3511294 300mg
AUC(0-t) of GSK3511294 300 mg1855.619 ± 25.8
SecondaryArea Under the Concentration-time Curve From Time Zero to Week 4 (AUC[0-Week 4]) of GSK3511294

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-Week 4). Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, and 4 post-dose
Reported as:
Geometric mean · Day*microgram per milliliter
Area Under the Concentration-time Curve From Time Zero to Week 4 (AUC[0-Week 4]) of GSK3511294
Day*microgram per milliliterGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
Area Under the Concentration-time Curve From Time Zero to Week 4 (AUC[0-Week 4]) of GSK35112946.856 ± 22.019.685 ± 14.062.994 ± 40.6292.698 ± 11.0676.055 ± 22.7
SecondaryArea Under the Concentration-time Curve From Time Zero to Week 12 (AUC[0-Week 12]) of GSK3511294

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-Week 12). Pharmacokinetic parameters were calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8 and 12 post-dose
Reported as:
Geometric mean · Day*microgram per milliliter
Area Under the Concentration-time Curve From Time Zero to Week 12 (AUC[0-Week 12]) of GSK3511294
Day*microgram per milliliterGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
Area Under the Concentration-time Curve From Time Zero to Week 12 (AUC[0-Week 12]) of GSK351129416.102 ± 37.148.389 ± 22.7148.798 ± 37.8663.984 ± 8.11445.726 ± 23.8
SecondaryArea Under the Concentration-time Curve From Time Zero to Week 26 (AUC [0-Week 26]) of GSK3511294

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-Week 26). Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26 post-dose
Reported as:
Geometric mean · Day*microgram per milliliter
Area Under the Concentration-time Curve From Time Zero to Week 26 (AUC [0-Week 26]) of GSK3511294
Day*microgram per milliliterGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
Area Under the Concentration-time Curve From Time Zero to Week 26 (AUC [0-Week 26]) of GSK351129421.829 ± 42.764.453 ± 24.3199.893 ± 39.9805.359 ± 7.71789.451 ± 26.3
SecondaryPercentage of AUC (0-inf) Obtained by Extrapolation (%AUCex) of GSK3511294 2 mg and 10 mg

Blood samples were collected from participants at indicated time points and analyzed for %AUCex. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose
Reported as:
Geometric mean · Percentage of AUCex
Percentage of AUC (0-inf) Obtained by Extrapolation (%AUCex) of GSK3511294 2 mg and 10 mg
Percentage of AUCexGSK3511294 2mgGSK3511294 10mg
Percentage of AUC (0-inf) Obtained by Extrapolation (%AUCex) of GSK3511294 2 mg and 10 mg24.3560 ± 35.87.7705 ± 81.6
Secondary%AUCex of GSK3511294 30 mg and 100 mg

Blood samples were collected from participants at indicated time points and analyzed for %AUCex. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose
Reported as:
Geometric mean · Percentage of AUCex
%AUCex of GSK3511294 30 mg and 100 mg
Percentage of AUCexGSK3511294 30mgGSK3511294 100mg
%AUCex of GSK3511294 30 mg and 100 mg2.9636 ± 55.61.4162 ± 88.3
Secondary%AUCex of GSK3511294 300 mg

Blood samples were collected from participants at indicated time points and analyzed for %AUCex. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose
Reported as:
Geometric mean · Percentage of AUCex
%AUCex of GSK3511294 300 mg
Percentage of AUCexGSK3511294 300mg
%AUCex of GSK3511294 300 mg0.9096 ± 35.1
SecondaryMaximum Observed Concentration (Cmax) of GSK3511294 2 mg and 10 mg

Blood samples were collected from participants at indicated time points and analyzed for Cmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose
Reported as:
Geometric mean · Microgram per milliliter
Maximum Observed Concentration (Cmax) of GSK3511294 2 mg and 10 mg
Microgram per milliliterGSK3511294 2mgGSK3511294 10mg
Maximum Observed Concentration (Cmax) of GSK3511294 2 mg and 10 mg0.3400 ± 25.30.8759 ± 18.3
SecondaryCmax of GSK3511294 30 mg and 100 mg

Blood samples were collected from participants at indicated time points and analyzed for Cmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose
Reported as:
Geometric mean · Microgram per milliliter
Cmax of GSK3511294 30 mg and 100 mg
Microgram per milliliterGSK3511294 30mgGSK3511294 100mg
Cmax of GSK3511294 30 mg and 100 mg2.8101 ± 41.112.2471 ± 15.9
SecondaryCmax of GSK3511294 300 mg

Blood samples were collected from participants at indicated time points and analyzed for Cmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose
Reported as:
Geometric mean · Microgram per milliliter
Cmax of GSK3511294 300 mg
Microgram per milliliterGSK3511294 300mg
Cmax of GSK3511294 300 mg28.5987 ± 23.3
SecondaryTime of Occurrence of Cmax (Tmax) of GSK3511294 2 mg and 10 mg

Blood samples were collected from participants at indicated time points and analyzed for Tmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose
Reported as:
Median · Days
Time of Occurrence of Cmax (Tmax) of GSK3511294 2 mg and 10 mg
DaysGSK3511294 2mgGSK3511294 10mg
Time of Occurrence of Cmax (Tmax) of GSK3511294 2 mg and 10 mg10.966 (6.99 to 27.98)7.956 (7.00 to 28.91)
SecondaryTmax of GSK3511294 30 mg and 100 mg

Blood samples were collected from participants at indicated time points and analyzed for Tmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose
Reported as:
Median · Days
Tmax of GSK3511294 30 mg and 100 mg
DaysGSK3511294 30mgGSK3511294 100mg
Tmax of GSK3511294 30 mg and 100 mg13.943 (4.00 to 28.02)13.970 (3.97 to 16.00)
SecondaryTmax of GSK3511294 300 mg

Blood samples were collected from participants at indicated time points and analyzed for Tmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose
Reported as:
Median · Days
Tmax of GSK3511294 300 mg
DaysGSK3511294 300mg
Tmax of GSK3511294 300 mg13.909 (2.00 to 15.00)
SecondaryTime of Last Quantifiable Concentration (Tlast) of GSK3511294 2 mg and 10 mg

Blood samples were collected from participants at indicated time points and analyzed for Tlast. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose
Reported as:
Median · Days
Time of Last Quantifiable Concentration (Tlast) of GSK3511294 2 mg and 10 mg
DaysGSK3511294 2mgGSK3511294 10mg
Time of Last Quantifiable Concentration (Tlast) of GSK3511294 2 mg and 10 mg84.47 (84.0 to 182.0)176.46 (126.0 to 185.0)
SecondaryTlast of GSK3511294 30 mg and 100 mg

Blood samples were collected from participants at indicated time points and analyzed for Tlast. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose
Reported as:
Median · Days
Tlast of GSK3511294 30 mg and 100 mg
DaysGSK3511294 30mgGSK3511294 100mg
Tlast of GSK3511294 30 mg and 100 mg182.01 (182.0 to 254.8)252.00 (250.0 to 255.0)
SecondaryTlast of GSK3511294 300 mg

Blood samples were collected from participants at indicated time points and analyzed for Tlast. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose
Reported as:
Median · Days
Tlast of GSK3511294 300 mg
DaysGSK3511294 300mg
Tlast of GSK3511294 300 mg279.99 (278.0 to 283.0)
SecondaryApparent Clearance Following Subcutaneous Dosing (CL/F) of GSK3511294 2 mg and 10 mg

Blood samples were collected from participants at indicated time points and analyzed for CL/F. CL/F was calculated as dose divided by AUC(0-inf). Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose
Reported as:
Geometric mean · Liters per day
Apparent Clearance Following Subcutaneous Dosing (CL/F) of GSK3511294 2 mg and 10 mg
Liters per dayGSK3511294 2mgGSK3511294 10mg
Apparent Clearance Following Subcutaneous Dosing (CL/F) of GSK3511294 2 mg and 10 mg0.08066 ± 51.60.14513 ± 23.6
SecondaryCL/F of GSK3511294 30 mg and 100 mg

Blood samples were collected from participants at indicated time points and analyzed for CL/F. CL/F was calculated as dose divided by AUC(0-inf). Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose
Reported as:
Geometric mean · Liters per day
CL/F of GSK3511294 30 mg and 100 mg
Liters per dayGSK3511294 30mgGSK3511294 100mg
CL/F of GSK3511294 30 mg and 100 mg0.14402 ± 39.60.11811 ± 7.3
SecondaryCL/F of GSK3511294 300 mg

Blood samples were collected from participants at indicated time points and analyzed for CL/F. CL/F was calculated as dose divided by AUC(0-inf). Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose
Reported as:
Geometric mean · Liters per day
CL/F of GSK3511294 300 mg
Liters per dayGSK3511294 300mg
CL/F of GSK3511294 300 mg0.16011 ± 25.5
SecondaryApparent Volume of Distribution After Subcutaneous Administration (Vd/F) of GSK3511294 2 mg and 10 mg

Blood samples were collected from participants at indicated time points and analyzed for Vd/F. Vd/F was calculated as dose divided by terminal elimination rate constant (lambda_z) \*AUC(0-inf). Pharmacokinetic parameters were calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose
Reported as:
Geometric mean · Liters
Apparent Volume of Distribution After Subcutaneous Administration (Vd/F) of GSK3511294 2 mg and 10 mg
LitersGSK3511294 2mgGSK3511294 10mg
Apparent Volume of Distribution After Subcutaneous Administration (Vd/F) of GSK3511294 2 mg and 10 mg6.113 ± 37.69.193 ± 34.7
SecondaryVd/F of GSK3511294 30 mg and 100 mg

Blood samples were collected from participants at indicated time points and analyzed for Vd/F. Vd/F was calculated as dose divided by \[lambda_z \*AUC(0-inf)\]. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose
Reported as:
Geometric mean · Liters
Vd/F of GSK3511294 30 mg and 100 mg
LitersGSK3511294 30mgGSK3511294 100mg
Vd/F of GSK3511294 30 mg and 100 mg7.812 ± 40.46.630 ± 12.1
SecondaryVd/F of GSK3511294 300 mg

Blood samples were collected from participants at indicated time points and analyzed for Vd/F. Vd/F was calculated as dose divided by \[lambda_z \*AUC(0-inf)\]. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose
Reported as:
Geometric mean · Liters
Vd/F of GSK3511294 300 mg
LitersGSK3511294 300mg
Vd/F of GSK3511294 300 mg9.337 ± 30.6
SecondaryTerminal Phase Elimination Rate Constant (Lambda_z) of GSK3511294 2 mg and 10 mg

Blood samples were collected from participants at indicated time points and analyzed for lambda_z. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose
Reported as:
Geometric mean · Day^-1
Terminal Phase Elimination Rate Constant (Lambda_z) of GSK3511294 2 mg and 10 mg
Day^-1GSK3511294 2mgGSK3511294 10mg
Terminal Phase Elimination Rate Constant (Lambda_z) of GSK3511294 2 mg and 10 mg0.013195 ± 37.30.015787 ± 16.2
SecondaryLambda_z of GSK3511294 30 mg and 100 mg

Blood samples were collected from participants at indicated time points and analyzed for lambda_z. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose
Reported as:
Geometric mean · Day^-1
Lambda_z of GSK3511294 30 mg and 100 mg
Day^-1GSK3511294 30mgGSK3511294 100mg
Lambda_z of GSK3511294 30 mg and 100 mg0.018435 ± 10.70.017813 ± 11.7
SecondaryLambda_z of GSK3511294 300 mg

Blood samples were collected from participants at indicated time points and analyzed for lambda_z. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose
Reported as:
Geometric mean · Day^-1
Lambda_z of GSK3511294 300 mg
Day^-1GSK3511294 300mg
Lambda_z of GSK3511294 300 mg0.017148 ± 6.3
SecondaryTerminal Phase Half-life (t1/2) of GSK3511294 2 mg and 10 mg

Blood samples were collected from participants at indicated time points and analyzed for t1/2. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose
Reported as:
Geometric mean · Days
Terminal Phase Half-life (t1/2) of GSK3511294 2 mg and 10 mg
DaysGSK3511294 2mgGSK3511294 10mg
Terminal Phase Half-life (t1/2) of GSK3511294 2 mg and 10 mg52.531 ± 37.343.907 ± 16.2
SecondaryT1/2 of GSK3511294 30 mg and 100 mg

Blood samples were collected from participants at indicated time points and analyzed for t1/2. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose
Reported as:
Geometric mean · Days
T1/2 of GSK3511294 30 mg and 100 mg
DaysGSK3511294 30mgGSK3511294 100mg
T1/2 of GSK3511294 30 mg and 100 mg37.599 ± 10.738.913 ± 11.7
SecondaryT1/2 of GSK3511294 300 mg

Blood samples were collected from participants at indicated time points and analyzed for t1/2. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Time frame:
Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose
Reported as:
Geometric mean · Days
T1/2 of GSK3511294 300 mg
DaysGSK3511294 300mg
T1/2 of GSK3511294 300 mg40.422 ± 6.3
SecondaryRatio to Baseline in Absolute Blood Eosinophil Count

Blood samples were collected at indicated time-points. Analysis was performed using a mixed model repeated measures analysis (MMRM) model on log-transformed data with fixed categorical effects of treatment, planned timepoint and treatment-by-planned timepoint interaction and fixed continuous covariates of log Baseline blood eosinophil count and log Baseline blood eosinophil count-by-planned timepoint interaction. Baseline is defined as the latest predose non-missing blood eosinophil count. Ratio to Baseline is defined as post-dose visit value divided by Baseline value. Pharmacodynamic Population included participants in the 'Safety' population for whom a post-dose pharmacodynamic (ie blood eosinophil) sample was obtained and analyzed.

Time frame:
Baseline, Days 2, 3, 4, 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36, and 40
Reported as:
Least squares mean · Ratio of eosinophils in blood
Ratio to Baseline in Absolute Blood Eosinophil Count
Ratio of eosinophils in bloodPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
Day 2, n=12, 6, 6, 8, 9, 61.083 (0.828 to 1.418)0.562 (0.382 to 0.827)0.522 (0.356 to 0.765)0.434 (0.313 to 0.601)0.496 (0.364 to 0.677)0.466 (0.317 to 0.683)
Day 3, n=12, 6, 6, 9, 9, 60.977 (0.747 to 1.279)0.431 (0.293 to 0.633)0.350 (0.238 to 0.512)0.281 (0.205 to 0.386)0.262 (0.192 to 0.357)0.403 (0.275 to 0.591)
Day 4, n=12, 6, 6, 8, 8, 61.008 (0.770 to 1.319)0.400 (0.272 to 0.589)0.340 (0.232 to 0.499)0.215 (0.155 to 0.298)0.250 (0.182 to 0.344)0.360 (0.246 to 0.528)
Day 5, n=11, 6, 6, 9, 9, 60.927 (0.705 to 1.220)0.300 (0.204 to 0.442)0.267 (0.182 to 0.391)0.219 (0.159 to 0.300)0.280 (0.205 to 0.382)0.299 (0.204 to 0.438)
Week 1, n=12, 6, 6, 9, 9, 51.136 (0.868 to 1.487)0.304 (0.206 to 0.447)0.223 (0.152 to 0.326)0.226 (0.165 to 0.311)0.237 (0.173 to 0.323)0.250 (0.167 to 0.373)
Week 2, n=12, 6, 5, 9, 9, 61.174 (0.897 to 1.536)0.274 (0.186 to 0.403)0.225 (0.151 to 0.336)0.170 (0.124 to 0.233)0.214 (0.157 to 0.292)0.265 (0.180 to 0.388)
Week 4,n=12, 6, 5, 9, 9, 61.062 (0.812 to 1.390)0.198 (0.134 to 0.291)0.195 (0.131 to 0.290)0.131 (0.095 to 0.179)0.185 (0.135 to 0.252)0.180 (0.123 to 0.264)
Week 8, n=12, 6, 6, 9, 9, 61.095 (0.837 to 1.434)0.201 (0.137 to 0.296)0.129 (0.088 to 0.189)0.102 (0.075 to 0.140)0.126 (0.092 to 0.172)0.178 (0.121 to 0.261)
Week 12, n=12, 5, 6, 9, 9, 51.031 (0.788 to 1.350)0.373 (0.250 to 0.557)0.171 (0.116 to 0.250)0.123 (0.089 to 0.168)0.161 (0.118 to 0.220)0.164 (0.110 to 0.244)
Week 18, n=12, 6, 6, 9, 9, 61.079 (0.824 to 1.412)0.466 (0.317 to 0.685)0.314 (0.214 to 0.460)0.152 (0.111 to 0.208)0.139 (0.102 to 0.190)0.179 (0.122 to 0.262)
Week 24, n=11, 6, 6, 9, 9, 61.005 (0.763 to 1.322)0.661 (0.449 to 0.972)0.563 (0.384 to 0.825)0.285 (0.208 to 0.391)0.149 (0.109 to 0.203)0.202 (0.137 to 0.296)
Week 26, n=12, 6, 6, 9, 9, 61.119 (0.855 to 1.464)0.776 (0.527 to 1.141)0.663 (0.452 to 0.972)0.317 (0.231 to 0.435)0.199 (0.146 to 0.271)0.186 (0.127 to 0.273)
Week 32, n=6, 6, 6, 0, 0, 60.912 (0.656 to 1.268)0.968 (0.655 to 1.430)0.837 (0.569 to 1.229)——0.210 (0.142 to 0.308)
Week 36, n=6, 0, 0, 9, 9, 00.975 (0.691 to 1.376)——0.858 (0.624 to 1.180)0.374 (0.274 to 0.511)—
Week 40, n=2, 0, 0, 0, 0, 61.210 (0.604 to 2.422)————0.258 (0.172 to 0.387)
SecondaryNumber of Participants With Anti-drug Antibody (ADA) Binding to GSK3511294

Serum samples were collected to determine the presence of anti-GSK3511294 binding antibodies using a validated bioanalytical method. Data for any time post-Baseline is reported. The results were categorized as negative, transient positive (defined as a single confirmatory positive immunogenic response that does not occur at the final study assessment) and persistent positive (defined as a confirmatory positive immunogenic response for at least 2 consecutive assessments or a single result at the final study assessment).

Time frame:
Up to Week 40
Reported as:
Count of participants · Participants
Number of Participants With Anti-drug Antibody (ADA) Binding to GSK3511294
ParticipantsPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
Negative1265475
Transient positive000010
Persistent positive001511
SecondaryTiters of Binding ADA to GSK3511294

Serum samples were collected to determine the presence of anti-GSK3511294 binding antibodies using a validated bioanalytical method. Data for any time post-Baseline is reported. Titer was only measured when a positive result was found.

Time frame:
Up to Week 40
Reported as:
Median · Titer
Titers of Binding ADA to GSK3511294
TiterPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
Titers of Binding ADA to GSK3511294——80.0 (80 to 80)160.0 (80 to 320)80.0 (80 to 80)80.0 (80 to 320)
PrimaryChange From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)

Blood samples were collected at indicated time-points for analysis of clinical parameters like ALP, AST and ALT. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Reported as:
Mean · International units per Liter
Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
International units per LiterPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
ALT, Day 2,n=12,6,5,9,9,6-0.3 ± 5.120.3 ± 3.564.0 ± 14.20-1.6 ± 2.07-0.1 ± 3.26-0.7 ± 2.73
ALT, Day 3,n=12,6,6,9,9,60.3 ± 5.962.5 ± 8.175.3 ± 17.94-0.6 ± 2.51-1.0 ± 3.201.2 ± 4.96
ALT, Day 4,n=12,6,6,9,9,61.0 ± 5.853.3 ± 11.084.2 ± 13.83-1.2 ± 1.86-0.1 ± 2.711.2 ± 3.43
ALT, Day 5,n=12,6,6,9,9,61.7 ± 7.962.0 ± 9.742.3 ± 8.91-0.6 ± 3.640.2 ± 3.424.5 ± 5.32
ALT, Week 1,n=12,6,6,9,9,51.2 ± 7.761.3 ± 5.922.8 ± 7.360.7 ± 3.610.6 ± 4.981.2 ± 5.54
ALT, Week 2,n=12,6,6,9,9,6-0.2 ± 5.57-5.3 ± 7.97-1.3 ± 4.320.3 ± 4.85-2.3 ± 4.973.0 ± 2.53
ALT, Week 4,n=12,6,6,9,9,6-0.3 ± 6.43-4.3 ± 7.630.7 ± 4.231.4 ± 9.41-2.6 ± 2.55-2.8 ± 4.36
ALT, Week 8,n=12,6,6,9,9,60.3 ± 7.25-3.3 ± 10.392.5 ± 6.53-1.6 ± 3.401.8 ± 9.56-3.0 ± 4.77
ALT, Week 12,n=12,6,6,9,9,6-0.9 ± 6.07-1.7 ± 4.180.5 ± 3.94-0.4 ± 1.943.0 ± 5.12-0.7 ± 2.66
ALT, Week 18,n=12,6,6,9,9,6-0.1 ± 6.13-3.5 ± 7.561.0 ± 10.301.9 ± 8.814.4 ± 6.93-0.7 ± 5.20
ALT, Week 24,n=12,6,6,9,9,60.3 ± 12.11-3.5 ± 7.645.2 ± 14.182.2 ± 10.767.3 ± 12.970.8 ± 5.34
ALT, Week 26,n=12,6,6,9,9,6-2.1 ± 6.13-0.8 ± 6.79-0.5 ± 6.475.1 ± 19.636.2 ± 13.082.5 ± 7.87
ALT, Week 32,n=6,6,6,0,0,61.5 ± 8.04-1.7 ± 9.89-1.0 ± 3.29——-3.0 ± 4.60
ALT, Week 36,n=6,0,0,9,9,00.3 ± 8.29——1.3 ± 6.865.0 ± 7.84—
ALT, Week 40,n=2,0,0,0,0,6-3.5 ± 7.78————1.2 ± 8.08
AST, Day 2,n=12,6,5,9,9,6-3.5 ± 3.55-1.2 ± 2.48-0.8 ± 7.19-2.6 ± 4.28-3.9 ± 5.42-3.7 ± 3.88
AST, Day 3,n=12,6,6,9,9,6-3.8 ± 4.86-0.8 ± 4.62-1.2 ± 7.22-1.8 ± 3.80-5.6 ± 6.58-3.2 ± 4.79
AST, Day 4,n=12,6,6,9,9,6-4.3 ± 4.27-0.8 ± 5.08-2.0 ± 4.34-2.9 ± 2.93-4.9 ± 6.33-3.3 ± 4.93
AST, Day 5,n=12,6,6,9,9,6-2.6 ± 4.10-0.5 ± 5.28-1.7 ± 3.67-3.2 ± 3.31-3.7 ± 7.57-2.0 ± 5.83
AST, Week 1,n=12,6,6,9,9,5-2.8 ± 4.120.0 ± 3.74-0.2 ± 2.32-1.9 ± 2.85-3.3 ± 4.53-4.6 ± 4.39
AST, Week 2,n=12,6,6,9,9,6-1.5 ± 4.66-0.3 ± 4.55-2.5 ± 2.881.0 ± 9.19-3.8 ± 6.44-0.7 ± 4.80
AST, Week 4,n=12,6,6,9,9,6-1.5 ± 3.97-2.3 ± 3.830.0 ± 6.030.0 ± 4.90-4.3 ± 6.87-4.2 ± 5.91
AST, Week 8,n=12,6,6,9,9,6-0.9 ± 7.45-1.8 ± 3.660.5 ± 3.02-0.2 ± 3.77-1.0 ± 10.58-4.7 ± 4.50
AST, Week 12,n=12,6,6,9,9,6-2.8 ± 2.79-1.2 ± 1.941.2 ± 3.71-1.2 ± 2.17-1.4 ± 6.98-2.0 ± 5.83
AST, Week 18,n=12,6,6,9,9,6-1.8 ± 4.14-1.2 ± 2.861.3 ± 10.09-0.7 ± 3.64-1.8 ± 5.56-3.3 ± 5.61
AST, Week 24,n=12,6,6,9,9,61.2 ± 18.521.3 ± 2.730.8 ± 5.42-1.1 ± 5.64-2.8 ± 8.76-1.8 ± 3.06
AST, Week 26,n=12,6,6,9,9,6-2.7 ± 4.081.8 ± 1.600.2 ± 3.370.0 ± 7.000.1 ± 9.210.2 ± 3.97
AST, Week 32,n=6,6,6,0,0,6-2.7 ± 3.390.5 ± 3.33-2.5 ± 1.52——-3.5 ± 5.47
AST, Week 36,n=6,0,0,9,9,0-1.0 ± 4.69——-2.0 ± 4.36-3.2 ± 6.70—
AST, Week 40,n=2,0,0,0,0,6-7.5 ± 6.36————3.0 ± 13.24
ALP, Day 2,n=12,6,5,9,9,6-1.8 ± 4.84-3.3 ± 1.371.0 ± 4.18-4.9 ± 2.801.3 ± 7.28-1.5 ± 7.77
ALP, Day 3,n=12,6,6,9,9,6-1.8 ± 5.66-2.7 ± 2.940.3 ± 8.52-1.8 ± 3.99-0.6 ± 5.320.2 ± 5.88
ALP, Day 4,n=12,6,6,9,9,6-1.7 ± 5.30-1.3 ± 3.200.0 ± 9.17-1.9 ± 3.62-0.2 ± 6.34-1.3 ± 6.09
ALP, Day 5,n=12,6,6,9,9,60.1 ± 5.74-2.0 ± 3.520.3 ± 4.76-1.4 ± 5.251.9 ± 9.44-1.2 ± 5.12
ALP, Week 1,n=12,6,6,9,9,50.2 ± 5.86-2.2 ± 5.56-2.5 ± 6.06-0.7 ± 6.18-1.1 ± 4.62-1.2 ± 7.53
ALP, Week 2,n=12,6,6,9,9,61.0 ± 3.44-8.2 ± 6.52-4.2 ± 3.54-0.6 ± 3.913.1 ± 5.25-1.0 ± 8.32
ALP, Week 4,n=12,6,6,9,9,61.4 ± 4.81-8.2 ± 8.30-1.2 ± 3.97-3.2 ± 4.322.6 ± 5.50-2.2 ± 7.81
ALP, Week 8,n=12,6,6,9,9,61.9 ± 6.88-2.0 ± 4.821.0 ± 10.06-4.4 ± 4.033.7 ± 3.61-0.8 ± 8.30
ALP, Week 12,n=12,6,6,9,9,6-0.6 ± 6.43-4.3 ± 7.097.2 ± 10.46-2.8 ± 2.823.1 ± 11.58-0.3 ± 5.09
ALP, Week 18,n=12,6,6,9,9,63.1 ± 6.82-2.0 ± 6.48-1.7 ± 4.841.9 ± 6.793.8 ± 8.27-3.5 ± 6.80
ALP, Week 24,n=12,6,6,9,9,63.8 ± 12.21-1.2 ± 7.94-1.0 ± 4.731.2 ± 10.515.8 ± 8.39-0.7 ± 6.74
ALP, Week 26,n=12,6,6,9,9,63.2 ± 8.64-6.2 ± 8.30-2.2 ± 4.020.4 ± 10.754.8 ± 8.24-1.7 ± 6.02
ALP, Week 32,n=6,6,6,0,0,6-2.0 ± 8.51-3.3 ± 8.500.2 ± 5.31——-1.0 ± 7.72
ALP, Week 36,n=6,0,0,9,9,09.0 ± 15.57——-0.6 ± 11.197.2 ± 8.39—
ALP, Week 40,n=2,0,0,0,0,6-5.5 ± 0.71————-3.7 ± 9.48
PrimaryChange From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium

Blood samples were collected at indicated time-points for analysis of clinical parameters like glucose, calcium, potassium, sodium, BUN, and magnesium. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Time frame:
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Reported as:
Mean · Millimoles per liter
Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Millimoles per literPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
Glucose, Day 2,n=12,6,5,9,9,60.06 ± 0.912-0.13 ± 0.4180.14 ± 0.439-0.11 ± 0.533-0.72 ± 0.9480.20 ± 0.352
Glucose, Day 3,n=12,6,6,9,9,6-0.28 ± 0.673-0.10 ± 1.215-0.93 ± 1.117-0.18 ± 0.455-0.21 ± 0.6470.15 ± 0.521
Glucose, Day 4,n=12,6,6,9,9,6-0.11 ± 0.7120.12 ± 0.987-0.33 ± 0.8570.26 ± 0.940-0.34 ± 1.3640.50 ± 1.103
Glucose, Day 5,n=12,6,6,9,9,6-0.06 ± 0.647-0.07 ± 0.6120.28 ± 0.9580.01 ± 0.775-0.17 ± 0.7280.05 ± 0.539
Glucose, Week 1,n=11,6,6,9,9,50.00 ± 0.656-0.35 ± 0.394-0.18 ± 1.280-0.20 ± 0.624-0.23 ± 1.0150.50 ± 1.345
Glucose, Week 2,n=12,6,6,9,9,60.03 ± 0.396-0.05 ± 0.2950.00 ± 0.525-0.02 ± 1.027-0.18 ± 0.902-0.10 ± 0.155
Glucose, Week 4,n=12,6,6,9,9,60.19 ± 0.783-0.33 ± 0.5430.03 ± 0.582-0.28 ± 0.678-0.08 ± 0.9190.33 ± 0.476
Glucose, Week 8,n=12,6,6,9,9,60.06 ± 0.444-0.42 ± 0.5850.27 ± 0.8240.04 ± 0.430-0.36 ± 1.1930.42 ± 0.722
Glucose, Week 12,n=12,6,6,9,9,60.32 ± 0.606-0.15 ± 0.4280.13 ± 1.0930.08 ± 0.905-0.66 ± 0.7600.23 ± 0.432
Glucose, Week 18,n=12,6,6,9,9,60.03 ± 0.548-0.02 ± 0.3310.42 ± 1.017-0.17 ± 0.541-0.23 ± 0.8250.15 ± 0.288
Glucose, Week 24,n=12,6,6,9,9,60.38 ± 1.131-0.13 ± 0.3330.02 ± 0.773-0.27 ± 0.654-0.26 ± 0.9280.50 ± 0.590
Glucose, Week 26,n=12,6,6,9,9,60.18 ± 0.506-0.10 ± 0.3460.62 ± 1.144-0.09 ± 0.362-0.22 ± 0.7580.38 ± 0.445
Glucose, Week 32,n=6,6,6,0,0,60.40 ± 1.2330.02 ± 0.194-0.28 ± 0.703——0.32 ± 0.354
Glucose, Week 36,n=6,0,0,9,9,00.17 ± 0.493——-0.26 ± 0.436-0.07 ± 0.996—
Glucose, Week 40,n=2,0,0,0,0,60.40 ± 0.566————0.23 ± 0.769
Calcium, Day 2,n=12,6,5,9,9,6-0.025 ± 0.0645-0.027 ± 0.0615-0.004 ± 0.0865-0.049 ± 0.07360.016 ± 0.12070.043 ± 0.0480
Calcium, Day 3,n=12,6,6,9,9,60.008 ± 0.0833-0.033 ± 0.10090.027 ± 0.1041-0.011 ± 0.0756-0.022 ± 0.10120.070 ± 0.0415
Calcium, Day 4,n=12,6,6,9,9,60.012 ± 0.0658-0.017 ± 0.06120.017 ± 0.0794-0.033 ± 0.0762-0.007 ± 0.07140.073 ± 0.0301
Calcium, Day 5,n=12,6,6,9,9,6-0.023 ± 0.0738-0.050 ± 0.08460.003 ± 0.0942-0.040 ± 0.0640-0.031 ± 0.09330.043 ± 0.0843
Calcium, Week 1,n=11,6,6,9,9,5-0.009 ± 0.0745-0.047 ± 0.07230.017 ± 0.0916-0.044 ± 0.0847-0.029 ± 0.0657-0.040 ± 0.0663
Calcium, Week 2,n=12,6,6,9,9,6-0.007 ± 0.0634-0.013 ± 0.0547-0.033 ± 0.0855-0.002 ± 0.08630.062 ± 0.07710.013 ± 0.0163
Calcium, Week 4,n=12,6,6,9,9,6-0.040 ± 0.0615-0.027 ± 0.0766-0.013 ± 0.1198-0.031 ± 0.07290.022 ± 0.09770.033 ± 0.0301
Calcium, Week 8,n=12,6,6,9,9,60.000 ± 0.0621-0.007 ± 0.1171-0.003 ± 0.0898-0.024 ± 0.07670.031 ± 0.0906-0.003 ± 0.0612
Calcium, Week 12,n=12,6,6,9,9,6-0.017 ± 0.0489-0.060 ± 0.0657-0.003 ± 0.1274-0.020 ± 0.07550.036 ± 0.0581-0.003 ± 0.0794
Calcium, Week 18,n=12,6,6,9,9,60.003 ± 0.0918-0.013 ± 0.0826-0.033 ± 0.08450.007 ± 0.08600.031 ± 0.08010.010 ± 0.0690
Calcium, Week 24,n=12,6,6,9,9,6-0.035 ± 0.0452-0.053 ± 0.06770.007 ± 0.0864-0.016 ± 0.09420.022 ± 0.12180.027 ± 0.0797
Calcium, Week 26,n=12,6,6,9,9,6-0.018 ± 0.0731-0.067 ± 0.0532-0.017 ± 0.1255-0.056 ± 0.02600.013 ± 0.0529-0.010 ± 0.0767
Calcium, Week 32,n=6,6,6,0,0,6-0.020 ± 0.10200.027 ± 0.07760.020 ± 0.0867——0.010 ± 0.0724
Calcium, Week 36,n=6,0,0,9,9,00.000 ± 0.0607——-0.013 ± 0.06240.029 ± 0.0813—
Calcium, Week 40,n=2,0,0,0,0,60.000 ± 0.1131————0.043 ± 0.0774
Potassium, Day 2,n=12,6,5,9,9,6-0.03 ± 0.2300.02 ± 0.1790.44 ± 0.3650.06 ± 0.3970.18 ± 0.3070.17 ± 0.234
Potassium, Day 3,n=12,6,6,9,9,6-0.07 ± 0.2900.03 ± 0.2580.02 ± 0.2040.14 ± 0.3320.01 ± 0.1360.12 ± 0.194
Potassium, Day 4,n=12,6,6,9,9,60.13 ± 0.1960.05 ± 0.4720.08 ± 0.2320.03 ± 0.2180.06 ± 0.2460.27 ± 0.163
Potassium, Day 5,n=12,6,6,9,9,60.11 ± 0.3030.10 ± 0.2760.00 ± 0.1260.11 ± 0.2670.04 ± 0.2070.15 ± 0.217
Potassium, Week 1,n=11,6,6,9,9,5-0.02 ± 0.3400.05 ± 0.4510.18 ± 0.1940.22 ± 0.3420.07 ± 0.3000.00 ± 0.200
Potassium, Week 2,n=12,6,6,9,9,60.00 ± 0.3160.05 ± 0.3150.20 ± 0.341-0.04 ± 0.2010.09 ± 0.3520.02 ± 0.299
Potassium, Week 4,n=12,6,6,9,9,60.00 ± 0.276-0.07 ± 0.3720.27 ± 0.344-0.04 ± 0.2830.11 ± 0.1960.00 ± 0.276
Potassium, Week 8,n=12,6,6,9,9,60.18 ± 0.2340.00 ± 0.3520.12 ± 0.1170.00 ± 0.2690.14 ± 0.207-0.05 ± 0.207
Potassium, Week 12,n=12,6,6,9,9,6-0.02 ± 0.383-0.02 ± 0.3870.12 ± 0.3310.00 ± 0.2780.04 ± 0.2130.03 ± 0.273
Potassium, Week 18,n=12,6,6,9,9,6-0.02 ± 0.3430.00 ± 0.3290.07 ± 0.2340.03 ± 0.2870.13 ± 0.3080.02 ± 0.293
Potassium, Week 24,n=12,6,6,9,9,6-0.03 ± 0.458-0.02 ± 0.3970.03 ± 0.2340.12 ± 0.291-0.04 ± 0.2600.07 ± 0.288
Potassium, Week 26,n=12,6,6,9,9,6-0.13 ± 0.360-0.03 ± 0.4800.00 ± 0.179-0.01 ± 0.2800.07 ± 0.2350.07 ± 0.327
Potassium, Week 32,n=6,6,6,0,0,6-0.15 ± 0.4760.03 ± 0.2420.12 ± 0.223——0.12 ± 0.147
Potassium, Week 36,n=6,0,0,9,9,00.07 ± 0.121——0.08 ± 0.3110.09 ± 0.215—
Potassium Week 40,n=2,0,0,0,0,6-0.35 ± 0.495————0.13 ± 0.356
Sodium, Day 2,n=12,6,5,9,9,60.8 ± 2.140.0 ± 1.900.0 ± 1.58-0.3 ± 1.940.9 ± 1.761.8 ± 1.72
Sodium, Day 3,n=12,6,6,9,9,61.2 ± 1.750.0 ± 0.890.3 ± 1.210.4 ± 1.330.9 ± 1.962.0 ± 1.55
Sodium, Day 4,n=12,6,6,9,9,61.1 ± 1.930.2 ± 1.600.0 ± 2.19-0.8 ± 2.110.3 ± 1.321.3 ± 1.86
Sodium, Day 5,n=12,6,6,9,9,61.3 ± 1.661.7 ± 1.51-1.3 ± 1.86-0.2 ± 2.220.8 ± 2.051.7 ± 1.75
Sodium, Week 1,n=11,6,6,9,9,50.8 ± 2.140.8 ± 2.32-1.7 ± 1.030.1 ± 1.45-0.1 ± 1.690.4 ± 2.19
Sodium, Week 2,n=12,6,6,9,9,60.1 ± 1.511.0 ± 1.26-0.7 ± 1.510.0 ± 1.32-0.3 ± 1.661.0 ± 2.28
Sodium, Week 4,n=12,6,6,9,9,60.0 ± 2.041.0 ± 1.41-1.2 ± 0.98-1.2 ± 1.30-0.6 ± 1.671.0 ± 1.41
Sodium, Week 8,n=12,6,6,9,9,60.1 ± 1.930.0 ± 2.53-0.5 ± 1.52-0.7 ± 1.94-1.1 ± 1.051.5 ± 3.45
Sodium, Week 12,n=12,6,6,9,9,60.0 ± 2.001.0 ± 1.26-0.8 ± 1.47-0.2 ± 1.56-0.3 ± 1.221.3 ± 2.25
Sodium, Week 18,n=12,6,6,9,9,60.1 ± 1.51-0.7 ± 2.25-1.0 ± 1.10-0.7 ± 1.220.0 ± 1.660.8 ± 1.60
Sodium, Week 24,n=12,6,6,9,9,60.3 ± 2.02-0.2 ± 1.60-1.5 ± 1.22-0.9 ± 2.370.2 ± 1.641.2 ± 1.72
Sodium, Week 26,n=12,6,6,9,9,60.2 ± 1.400.0 ± 1.90-0.7 ± 2.88-1.1 ± 2.15-1.1 ± 1.541.7 ± 1.97
Sodium, Week 32,n=6,6,6,0,0,60.3 ± 2.250.5 ± 3.56-1.8 ± 1.17——0.7 ± 2.07
Sodium, Week 36,n=6,0,0,9,9,0-0.3 ± 2.66——-0.9 ± 1.90-1.3 ± 1.00—
Sodium, Week 40,n=2,0,0,0,0,60.5 ± 2.12————0.0 ± 1.90
Magnesium, Day 2,n=12,6,5,9,9,6-0.020 ± 0.0467-0.037 ± 0.05850.008 ± 0.06420.000 ± 0.0361-0.036 ± 0.0623-0.020 ± 0.0310
Magnesium, Day 3,n=12,6,6,9,9,6-0.012 ± 0.0542-0.043 ± 0.0388-0.003 ± 0.07090.007 ± 0.0283-0.064 ± 0.0564-0.037 ± 0.0427
Magnesium, Day 4,n=12,6,6,9,9,6-0.013 ± 0.0750-0.020 ± 0.0310-0.007 ± 0.0575-0.007 ± 0.0283-0.060 ± 0.0490-0.047 ± 0.0628
Magnesium, Day 5,n=12,6,6,9,9,6-0.017 ± 0.0545-0.047 ± 0.0745-0.033 ± 0.04130.007 ± 0.0283-0.036 ± 0.0536-0.020 ± 0.0632
Magnesium, Week 1,n=11,6,6,9,9,5-0.004 ± 0.0427-0.003 ± 0.06380.017 ± 0.0480-0.007 ± 0.0520-0.040 ± 0.0346-0.032 ± 0.0460
Magnesium, Week 2,n=12,6,6,9,9,60.005 ± 0.0410-0.003 ± 0.05130.033 ± 0.04840.018 ± 0.0570-0.036 ± 0.0445-0.027 ± 0.0501
Magnesium, Week 4,n=12,6,6,9,9,60.007 ± 0.0345-0.033 ± 0.05890.000 ± 0.04560.007 ± 0.0346-0.027 ± 0.0529-0.017 ± 0.0408
Magnesium, Week 8,n=12,6,6,9,9,6-0.003 ± 0.0608-0.027 ± 0.0501-0.007 ± 0.04840.016 ± 0.0240-0.018 ± 0.0338-0.003 ± 0.0585
Magnesium, Week 12,n=12,6,6,9,9,6-0.013 ± 0.0492-0.043 ± 0.06860.000 ± 0.05510.011 ± 0.0448-0.011 ± 0.05010.000 ± 0.0456
Magnesium, Week 18,n=12,6,6,9,9,60.017 ± 0.0525-0.030 ± 0.05760.000 ± 0.04560.000 ± 0.0566-0.036 ± 0.07730.000 ± 0.0551
Magnesium, Week 24,n=12,6,6,9,9,60.008 ± 0.0422-0.023 ± 0.0585-0.017 ± 0.06860.000 ± 0.0424-0.047 ± 0.0557-0.003 ± 0.0320
Magnesium, Week 26,n=12,6,6,9,9,60.002 ± 0.0542-0.057 ± 0.0320-0.017 ± 0.04630.000 ± 0.0469-0.036 ± 0.0477-0.027 ± 0.0432
Magnesium, Week 32,n=6,6,6,0,0,6-0.010 ± 0.0245-0.023 ± 0.04970.017 ± 0.0480——-0.027 ± 0.0301
Magnesium Week 36,n=6,0,0,9,9,0-0.013 ± 0.0532——0.004 ± 0.0133-0.013 ± 0.0447—
Magnesium, Week 40,n=2,0,0,0,0,60.030 ± 0.0424————-0.030 ± 0.0329
BUN, Day 2,n=12,6,5,9,9,6-0.83 ± 1.135-0.17 ± 0.4080.20 ± 1.304-0.67 ± 0.791-0.28 ± 0.833-1.25 ± 1.084
BUN, Day 3,n=12,6,6,9,9,6-0.79 ± 1.3730.00 ± 0.316-0.17 ± 0.931-0.72 ± 0.833-0.28 ± 0.755-1.17 ± 1.402
BUN, Day 4,n=12,6,6,9,9,6-0.75 ± 1.357-0.25 ± 0.274-0.33 ± 1.169-0.61 ± 0.9280.00 ± 0.707-0.50 ± 1.673
BUN, Day 5,n=12,6,6,9,9,6-0.71 ± 1.339-0.33 ± 0.8160.67 ± 1.169-0.61 ± 0.961-0.17 ± 0.968-0.67 ± 1.602
BUN, Week 1,n=11,6,6,9,9,5-0.45 ± 1.150-0.50 ± 1.1830.50 ± 1.581-0.44 ± 1.0140.11 ± 0.782-1.10 ± 1.084
BUN, Week 2,n=12,6,6,9,9,6-0.33 ± 1.267-0.75 ± 1.0370.33 ± 1.7800.06 ± 0.726-0.17 ± 0.612-0.33 ± 1.080
BUN, Week 4,n=12,6,6,9,9,6-0.25 ± 1.098-0.75 ± 0.5240.75 ± 0.8220.22 ± 0.9720.17 ± 1.225-0.08 ± 1.114
BUN, Week 8,n=12,6,6,9,9,6-0.75 ± 0.989-0.17 ± 1.0331.17 ± 1.2520.06 ± 1.0740.28 ± 1.093-0.58 ± 1.158
BUN, Week 12,n=12,6,6,9,9,6-0.75 ± 1.3230.17 ± 0.9830.17 ± 0.816-0.06 ± 0.5270.06 ± 0.6820.25 ± 1.037
BUN, Week 18,n=12,6,6,9,9,6-1.08 ± 1.5050.50 ± 1.4140.58 ± 1.0680.39 ± 1.5160.00 ± 0.866-0.33 ± 0.983
BUN, Week 24,n=12,6,6,9,9,6-0.79 ± 1.389-0.17 ± 0.8761.42 ± 1.5940.11 ± 1.4530.33 ± 1.1460.17 ± 0.683
BUN, Week 26,n=12,6,6,9,9,6-0.38 ± 1.069-0.33 ± 0.9830.83 ± 1.366-0.17 ± 1.0000.22 ± 0.7550.08 ± 1.068
BUN, Week 32,n=6,6,6,0,0,6-1.00 ± 0.949-0.33 ± 0.6830.75 ± 1.405——-0.08 ± 0.801
BUN, Week 36,n=6,0,0,9,9,0-0.58 ± 1.855——-0.72 ± 1.0340.28 ± 1.228—
BUN, Week 40,n=2,0,0,0,0,6-1.00 ± 0.000————-0.42 ± 1.201
PrimaryNumber of Participants With Presence of Ketones, Glucose, Occult Blood, and Protein

Urine samples were collected to analyze presence of ketones, occult blood, glucose, and protein in urine. In this dipstick test, the level of occult blood, glucose, ketones and urine protein in urine samples were recorded as negative, trace, 1+ and 2+ indicating proportional concentrations in urine. Only categories with abnormal significant values have been presented.

Time frame:
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Reported as:
Count of participants · Participants
Number of Participants With Presence of Ketones, Glucose, Occult Blood, and Protein
ParticipantsPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
Occult blood, Trace,Week 4,n=2,1,1,5,0,11000—0
Urine Ketone, Trace,Day 2,n=1,2,0,2,0,010—0——
Urine Ketone, Trace, Day 4,n=0,0,1,1,0,0——10——
Urine Ketone, Trace, Day 5,n=2,0,0,2,1,01——00—
Urine Ketone, Trace, Week 1,n=2,1,1,3,0,01010——
Urine Ketone, Trace, Week 2,n=1,0,0,3,1,01——10—
Urine Ketone, Trace, Week 4,n=2,1,1,5,0,01010——
Urine Ketone, Trace, Week 18,n=2,1,0,1,0,01000——
Urine Ketone, Trace, Week 24,n=1,1,0,4,0,01000——
Urine Ketone, Trace, Week 26,n=0,0,0,2,0,0———1——
Urine Ketone, Trace,Week 32,n=1,0,0,0,0,01—————
Urine Ketone, 1+, Week 40,n=0,0,0,0,0,1—————1
Urine Protein, 2+, Week 4,n=2,1,1,5,0,11000—0
Urine Protein, Trace, Week 8,n=1,0,0,2,0,01——0——
Urine Protein, Trace, Week 18,n=2,1,0,1,0,010—0——
PrimaryUrine Potential of Hydrogen (pH) Analysis by Dipstick Method

Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).

Time frame:
Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Reported as:
Mean · pH
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method
pHPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
Day 2,n=1,1,0,2,0,05.00 ± NA7.00 ± NA—6.50 ± 1.414——
Day 3,n=3,0,0,1,0,06.00 ± 0.500——5.00 ± NA——
Day 4,n=0,0,1,1,0,0——6.50 ± NA5.00 ± NA——
Day 5,n=2,0,0,2,1,05.50 ± 0.707——5.75 ± 1.0615.50 ± NA—
Week 1,n=2,1,1,3,0,05.50 ± 0.0007.00 ± NA6.00 ± NA5.50 ± 0.500——
Week 2,n=1,0,0,4,1,05.50 ± NA——5.63 ± 0.4798.50 ± NA—
Week 4,n=3,1,1,5,0,16.50 ± 0.8668.00 ± NA5.50 ± NA6.00 ± 0.707—5.00 ± NA
Week 8,n=1,0,0,2,0,05.50 ± NA——5.50 ± 0.000——
Week 12,n=0,1,0,1,0,0—6.50 ± NA—5.00 ± NA——
Week 18,n=3,1,0,1,0,05.67 ± 0.5777.00 ± NA—5.00 ± NA——
Week 24,n=1,1,0,4,0,06.00 ± NA6.50 ± NA—5.38 ± 0.479——
Week 26,n=0,0,0,2,0,0———5.50 ± 0.000——
Week 32,n=1,0,0,0,0,07.50 ± NA—————
PrimaryAbsolute Values of Complement (C)3 and C4

Blood samples were collected at indicated timepoints for analysis for complement (C3 and C4). Baseline was defined as latest pre-dose assessment with a non-missing value.

Time frame:
Baseline and at Days 2, 3, 4 and 5; Weeks 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Reported as:
Geometric mean · Grams per liter
Absolute Values of Complement (C)3 and C4
Grams per literPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
C3, Baseline,n=12,6,6,9,9,61.149 (1.061 to 1.243)1.182 (0.995 to 1.404)1.086 (0.941 to 1.254)1.074 (0.982 to 1.175)1.137 (1.013 to 1.277)1.254 (1.122 to 1.402)
C3, Day 2,n=12,6,6,9,9,61.13 (1.042 to 1.225)1.27 (1.051 to 1.535)1.16 (0.940 to 1.433)1.114 (1.018 to 1.219)1.188 (1.053 to 1.341)1.286 (1.182 to 1.400)
C3, Day 3,n=12,6,6,9,9,61.187 (1.063 to 1.325)1.244 (1.029 to 1.503)1.236 (1.011 to 1.511)1.142 (1.037 to 1.258)1.157 (1.038 to 1.290)1.322 (1.197 to 1.460)
C3, Day 4,n=12,6,6,9,9,61.17 (1.051 to 1.302)1.284 (1.023 to 1.611)1.181 (1.016 to 1.374)1.144 (1.051 to 1.245)1.165 (1.038 to 1.307)1.316 (1.189 to 1.458)
C3, Day 5,n=12,6,6,9,9,61.136 (1.011 to 1.277)1.122 (0.993 to 1.268)1.092 (0.909 to 1.311)1.113 (1.011 to 1.226)1.165 (1.026 to 1.323)1.305 (1.159 to 1.469)
C3, Week 2,n=12,6,6,9,9,61.136 (1.062 to 1.215)1.147 (0.986 to 1.333)1.02 (0.841 to 1.238)1.139 (1.045 to 1.241)1.174 (1.039 to 1.327)1.28 (1.136 to 1.442)
C3, Week 4,n=12,6,6,9,9,61.114 (1.043 to 1.191)1.05 (0.873 to 1.262)1.111 (0.900 to 1.370)1.07 (0.957 to 1.197)1.148 (1.019 to 1.293)1.22 (1.085 to 1.372)
C3, Week 8,n=12,6,6,9,9,61.224 (1.150 to 1.303)1.226 (1.115 to 1.347)1.097 (0.875 to 1.376)1.117 (0.993 to 1.257)1.167 (1.085 to 1.254)1.34 (1.191 to 1.506)
C3, Week 12,n=12,6,6,9,9,61.117 (1.011 to 1.234)1.033 (0.935 to 1.141)1.124 (0.947 to 1.334)1.147 (1.050 to 1.254)1.211 (1.065 to 1.377)1.28 (1.117 to 1.465)
C3, Week 18,n=12,6,6,9,9,61.173 (1.065 to 1.291)1.215 (0.984 to 1.500)1.124 (0.922 to 1.370)1.184 (1.045 to 1.342)1.231 (1.119 to 1.353)1.283 (1.158 to 1.422)
C3, Week 24,n=12,6,6,8,9,61.15 (1.067 to 1.238)1.136 (1.031 to 1.252)1.171 (1.029 to 1.332)1.157 (1.019 to 1.312)1.243 (1.107 to 1.395)1.222 (1.100 to 1.356)
C3, Week 26,n=12,6,6,9,9,61.204 (1.106 to 1.311)0.927 (0.450 to 1.910)1.142 (0.963 to 1.355)1.156 (1.070 to 1.249)1.222 (1.081 to 1.381)1.298 (1.123 to 1.501)
C3, Week 32,n=6,6,6,0,0,61.173 (0.985 to 1.398)1.243 (1.137 to 1.358)1.231 (1.016 to 1.491)——1.204 (1.116 to 1.299)
C3, Week 36,n=6,0,0,9,9,01.243 (1.107 to 1.397)——1.188 (1.085 to 1.301)1.236 (1.106 to 1.382)—
C3, Week 40,n=2,0,0,0,0,61.181 (NA to NA)————1.231 (1.069 to 1.417)
C4, Baseline,n=12,6,6,9,9,60.2576 (0.2108 to 0.3147)0.2061 (0.1653 to 0.2570)0.1919 (0.1337 to 0.2755)0.2144 (0.1727 to 0.2663)0.1939 (0.1496 to 0.2512)0.215 (0.1859 to 0.2488)
C4, Day 2,n=12,6,6,9,9,60.2525 (0.2037 to 0.3130)0.2161 (0.1832 to 0.2549)0.2061 (0.1469 to 0.2891)0.2133 (0.1784 to 0.2549)0.203 (0.1597 to 0.2581)0.22 (0.1832 to 0.2643)
C4, Day 3,n=12,6,6,9,9,60.2647 (0.2068 to 0.3389)0.2038 (0.1685 to 0.2464)0.2212 (0.1464 to 0.3342)0.2142 (0.1759 to 0.2609)0.1962 (0.1514 to 0.2544)0.223 (0.1921 to 0.2589)
C4, Day 4,n=12,6,6,9,9,60.253 (0.2013 to 0.3179)0.2303 (0.1918 to 0.2767)0.2006 (0.1416 to 0.2842)0.2128 (0.1766 to 0.2564)0.1935 (0.1472 to 0.2543)0.2188 (0.1867 to 0.2564)
C4, Day 5,n=12,6,6,9,9,60.2497 (0.1929 to 0.3232)0.1892 (0.1572 to 0.2277)0.1866 (0.1327 to 0.2680)0.2073 (0.1685 to 0.2551)0.1943 (0.1492 to 0.2531)0.2163 (0.1869 to 0.2503)
C4, Week 2,n=12,6,6,9,9,60.2555 (0.2028 to 0.3220)0.2108 (0.1768 to 0.2514)0.1781 (0.1172 to 0.2706)0.221 (0.1813 to 0.2695)0.2018 (0.1497 to 0.2720)0.2169 (0.1765 to 0.2664)
C4, Week 4,n=12,6,6,9,9,60.2602 (0.2078 to 0.3258)0.1928 (0.1623 to 0.2290)0.189 (0.1292 to 0.2766)0.2063 (0.1636 to 0.2602)0.1872 (0.1419 to 0.2468)0.1929 (0.1733 to 0.2146)
C4, Week 8,n=12,6,6,9,9,60.2738 (0.2186 to 0.3431)0.2547 (0.2010 to 0.3226)0.2045 (0.1315 to 0.3180)0.2009 (0.1654 to 0.2441)0.1901 (0.1542 to 0.2343)0.2231 (0.1778 to 0.2800)
C4, Week 12,n=12,6,6,9,9,60.2413 (0.1901 to 0.3063)0.1862 (0.1567 to 0.2213)0.2034 (0.1307 to 0.3167)0.2114 (0.1723 to 0.2594)0.196 (0.1494 to 0.2572)0.2074 (0.1792 to 0.2400)
C4, Week 18,n=12,6,6,9,9,60.261 (0.1992 to 0.3420)0.2266 (0.1873 to 0.2742)0.2025 (0.1322 to 0.3102)0.226 (0.1920 to 0.2660)0.1678 (0.1255 to 0.2245)0.216 (0.1740 to 0.2681)
C4, Week 24,n=12,6,6,8,9,60.2474 (0.1894 to 0.3232)0.2244 (0.1742 to 0.2890)0.197 (0.1324 to 0.2932)0.206 (0.1801 to 0.2357)0.1909 (0.1500 to 0.2430)0.2114 (0.1682 to 0.2658)
C4, Week 26,n=12,6,6,9,9,60.2517 (0.1926 to 0.3291)0.202 (0.1319 to 0.3095)0.1939 (0.1291 to 0.2912)0.2115 (0.1704 to 0.2627)0.163 (0.1250 to 0.2126)0.226 (0.1887 to 0.2627)
C4, Week 32,n=6,6,6,0,0,60.2772 (0.1617 to 0.4754)0.2401 (0.2003 to 0.2877)0.2007 (0.1297 to 0.3105)——0.2051 (0.1808 to 0.2326)
C4, Week 36,n=6,0,0,9,9,00.2844 (0.2110 to 0.3834)——0.2025 (0.1637 to 0.2504)0.206 (0.1626 to 0.2611)—
C4, Week 40,n=2,0,0,0,0,60.1699 (NA to NA)————0.2134 (0.1766 to 0.2580)

Adverse events

Collected over Non-serious AEs and SAEs were collected from the start of the study treatment (Day 1) up to Week 32 for GSK3511294 2 mg and 10 mg, up to Week 36 for GSK3511294 30 mg and GSK3511294 100 mg and up to Week 40 for GSK3511294 300 mg; and up to 40 weeks for placebo.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/12 (0%)0/12 (0%)11/12 (91.7%)
GSK3511294 2mg0/6 (0%)0/6 (0%)2/6 (33.3%)
GSK3511294 10mg0/6 (0%)0/6 (0%)6/6 (100%)
GSK3511294 30mg0/9 (0%)0/9 (0%)8/9 (88.9%)
GSK3511294 100mg0/9 (0%)0/9 (0%)9/9 (100%)
GSK3511294 300mg0/6 (0%)0/6 (0%)4/6 (66.7%)
Most frequent other events
Showing 10 of 67
Most frequent other events
EventPlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mg
NasopharyngitisInfections and infestations2/122/61/63/95/92/6
HeadacheNervous system disorders0/121/61/62/93/92/6
Rib fractureInjury, poisoning and procedural complications0/120/62/60/90/90/6
DyspepsiaGastrointestinal disorders0/120/62/60/90/90/6
Seasonal allergyImmune system disorders2/121/62/62/91/91/6
RhinitisInfections and infestations3/120/61/61/92/90/6
CoughRespiratory, thoracic and mediastinal disorders3/120/60/60/90/90/6
GastroenteritisInfections and infestations0/120/60/60/92/90/6
Arthropod stingInjury, poisoning and procedural complications0/120/60/62/90/90/6
Oropharyngeal painRespiratory, thoracic and mediastinal disorders1/120/61/60/92/91/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)PlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mgTotal
Mean44.0 ± 13.3743.5 ± 10.7144.7 ± 13.2044.9 ± 10.2342.0 ± 10.8445.2 ± 11.1844.0 ± 11.17
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mgTotal
Female0000112
Male126698546
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboGSK3511294 2mgGSK3511294 10mgGSK3511294 30mgGSK3511294 100mgGSK3511294 300mgTotal
Central/South Asian Heritage1001002
Black or African American (Afr. Amer.)0101002
Arabic/North African Heritage1000001
White/Caucasian/European Heritage95679642
Black/Afr. Amer./White/Caucasian/European Heritage1000001
08

Study locations

5 sites
  • GSK Investigational Site
    Hannover, Niedersachsen 30625, Germany
  • GSK Investigational Site
    Berlin, 14050, Germany
  • GSK Investigational Site
    Harrow, Middlesex HA1 3UJ, United Kingdom
  • GSK Investigational Site
    London, NW10 7EW, United Kingdom
  • GSK Investigational Site
    Manchester, M23 9QZ, United Kingdom
09

References and documents

Publications

  • Singh D, Fuhr R, Bird NP, Mole S, Hardes K, Man YL, Cahn A, Yancey SW, Pouliquen IJ. A Phase 1 study of the long-acting anti-IL-5 monoclonal antibody GSK3511294 in patients with asthma. Br J Clin Pharmacol. 2022 Feb;88(2):702-712. doi: 10.1111/bcp.15002. Epub 2021 Aug 24. PubMed 34292606 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request Site

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study

Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Data sharing details ↗ · clinicalstudydatarequest.com

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Jul 2019, 21 months.

Results were first posted in Mar 2021, 1 year 7 months after primary completion.

Of 173 industry-sponsored phase 1 interventional studies under Asthma, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 12. This study's 21 months is above that.

Counting every sponsor, half of 200 studies reached it within 6 months; a quarter within 3 and three quarters within 14.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2017
First posted
Sep 19, 2017
StartActual
Oct 17, 2017
Primary completionActual
Jul 31, 2019
CompletionActual
Jul 31, 2019
Results first posted
Mar 1, 2021
Last update
Mar 1, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03287310
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 19, 2017
Start date
Oct 17, 2017
Primary completion
Jul 31, 2019
Completion
Jul 31, 2019
Results posted
Mar 1, 2021
Last update
Mar 1, 2021

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Depemokimab

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GlaxoSmithKline →

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