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CompletedNCT05131971Updated Mar 26, 2025Results posted

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (PD) of GSK3888130B in Healthy Participants

A Phase 1 interventional study of GSK3888130B and Placebo in Multiple Sclerosis and Colitis, Ulcerative, sponsored by GlaxoSmithKline. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-26.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This is a first time in human study designed to assess the safety, tolerability, pharmacokinetics and PD of GSK3888130B over a range of dose levels in healthy participants.

02

Conditions studied

  • Multiple Sclerosis
  • Colitis, Ulcerative

Keywords

  • Anti-Drug Antibodies
  • Double-blind
  • GSK3888130B
  • Pharmacodynamics
  • Pharmacokinetics
  • Single Dose Escalation
03

In context

Colitis, Ulcerative

1,492 studies on the registry are indexed under Colitis, Ulcerative; 399 are open to participants now.

This study's enrollment of 54 is below the median of 71 across 1,042 interventional studies indexed under Colitis, Ulcerative.

Browse Colitis, Ulcerative studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Participant must be 18 to 55 years of age inclusive.
  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
  • Participants with a confirmed positive vaccination status for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccines administered at least 30 days prior to dosing in the study.
  • SARS-CoV-2 screening test negative as per local guidance.
  • Participants with history of current/seasonal vaccination status for influenza or who consent to receive influenza vaccine at least 30 days prior to dosing, if study dosing is during influenza season (1st October to 30th April).
  • Body weight greater than or equal to (>=) 50 kilograms (kg) and body mass index (BMI) within the range 19.5-32 kilograms per square meter (kg/m\^2) (inclusive).
  • Male and/or female of non-childbearing potential
  • Capable of giving signed informed consent.

Exclusion criteria

Exclusion Criteria:

  • Prior medical history of anaphylaxis.
  • Immunodeficiency or autoimmunity assessed by medical history.
  • A history of recurrent infections.
  • Treatment of a chronic infection within 3 months prior to the first dose of study drug.
  • Any acute infection (including upper respiratory tract infections and urinary tract infections) which has not fully resolved within four weeks of dosing
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy.
  • Current or chronic history of liver disease or known hepatic or biliary abnormalities.
  • Participants with a history of renal disease or renal abnormalities.
  • A clinically significant abnormality in the 12-lead ECG performed at screening.
  • A clinically significant abnormality in the Holter monitor performed at screening.
  • History of malignancy, including malignant or non-malignant skin cancer.
  • Participants with known SARS-CoV-2 positive contacts in the past 14 days.
  • Prior moderate/severe SARS-CoV-2 infection requiring oxygen supplementation or admission to hospital.
  • Antibiotics or antiviral therapy within 30 days of dosing.
  • Receipt of live vaccination within 30 days of dosing or plan to receive live vaccination during the study.
  • Use of prescription drugs or non-prescription drugs, including non-steroidal anti inflammatory drug (NSAIDs), within 7 days prior to dosing, if in the opinion of the Investigator (in consultation with the GlaxoSmithKline [GSK] Medical Monitor if required) the medication will interfere with the study procedures or compromise participant safety.
  • The participant has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day of the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Exposure to more than 4 new chemical entities within 12 months prior to dosing.
  • A positive drug/alcohol test at screening or Day -1
  • The participant is at high-risk of Mycobacterium tuberculosis (MTB) infection in the opinion of the Investigator.
  • History of asthma, allergic rhinitis or atopic dermatitis defined by the need for intermittent or continuous therapy or any other significant allergies that, in the opinion of the investigator contraindicates their participation.
  • History of severe adverse reaction to local anesthetic.
  • Presence of keloids or history of keloids.
  • Prothrombin time (PT) or activated partial thromboplastin time (aPTT) >1.5x upper limit of normal (ULN) at screening.
  • History or presence of excessive bleeding or coagulation disorders that in the opinion of the Investigator poses a safety risk with regards to participation in the trial.
  • Presence of tattoos, naevi or other skin abnormalities on the volar forearm Fitzpatrick skin color grades V in the opinion of the investigator, interfere with study assessments
  • Participating, within 7 days of dosing, in recreational sun-bathing, or use of sunbed, on the area of the skin from wrist to shoulder inclusive.
  • Current smoker or user of tobacco- or nicotine-containing products (e.g. nicotine patches or vaporizing devices) during or within 30 days prior to study participation.
  • An average weekly intake of >14 units of alcohol.
05

Study design

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

Study arms

  • Experimental
    Cohort 1: Participants receiving GSK3888130B at dose level 1

    Drug: GSK3888130B

  • Placebo comparator
    Cohort 1: Participants receiving placebo

    Drug: Placebo

  • Experimental
    Cohort 2: Participants receiving GSK3888130B at dose level 2

    Drug: GSK3888130B

  • Placebo comparator
    Cohort 2: Participants receiving placebo

    Drug: Placebo

  • Experimental
    Cohort 3: Participants receiving GSK3888130B at dose level 3

    Drug: GSK3888130B

  • Placebo comparator
    Cohort 3: Participants receiving placebo

    Drug: Placebo

  • Experimental
    Cohort 4: Participants receiving GSK3888130B at dose level 4

    Drug: GSK3888130B

  • Placebo comparator
    Cohort 4: Participants receiving placebo

    Drug: Placebo

  • Experimental
    Cohort 5: Participants receiving GSK3888130B at dose level 5

    Drug: GSK3888130B

  • Placebo comparator
    Cohort 5: Participants receiving placebo

    Drug: Placebo

  • Experimental
    Cohort 6: Participants receiving GSK3888130B at dose level 6

    Drug: GSK3888130B

  • Placebo comparator
    Cohort 6: Participants receiving placebo

    Drug: Placebo

  • Experimental
    Cohort 7: Participants receiving GSK3888130B at dose level 7

    Drug: GSK3888130B

  • Placebo comparator
    Cohort 7: Participants receiving placebo

    Drug: Placebo

Interventions

  • DrugGSK3888130B

    GSK3888130B will be administered.

  • DrugPlacebo

    Placebo will be administered.

06

What researchers measure

Primary outcomes

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

    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 any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

    Time frame: Up to 160 days

  2. Number of Participants With Clinically Significant Changes in Hematology Results

    Blood samples were collected for analysis of following hematology parameters: Basophils, Eosinophils, Hematocrit, Hemoglobin (Hg), Lymphocytes, Mean corpuscular Hg, Mean corpuscular volume, Monocytes, Platelet count, Red blood cell count, Reticulocytes, Total Neutrophils, and White blood cells count (WBC). Number of participants with clinically significant changes in hematology were reported. Clinical significance was determined by the investigator.

    Time frame: Up to 85 days

  3. Number of Participants With Worst-case Cluster of Differentiation (CD) 4+ T Cell Counts Results by Maximum Grade Increase Post-Baseline Relative to Baseline

    Blood samples were collected for the analysis of CD4+ T Cell Counts. The CD4+ T Cell Counts were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE). Grade 0: Above 0.5\*10\^9 cells/Liter (L), Grade 1: \<0.5 to 0.2\*10\^9 cells/L, Grade 2: \<0.2 to 0.05\*10\^9 cells/L, Grade 3: Below 0.05\*10\^9 cells/L. Baseline was defined as the latest pre-dose assessment. An increase was defined as an increase in grade relative to Baseline grade. Any worst-case post Baseline increase to Grade 1, Grade 2 and Grade 3 are presented.

    Time frame: Baseline (Day 1) and up to 85 days

  4. Number of Participants With Worst-case Creatinine Results by Maximum Grade Increase Post-Baseline Relative to Baseline

    Blood samples were collected for the analysis of Creatinine. Creatinine was graded according to the NCI-CTCAE. Grade 0: \<1.5\* Baseline, or increase from Baseline \<26 micromoles per liter (umol/L), Grade 1: 1.5 to 1.9\* Baseline, or increase from Baseline \>=26 umol/L, Grade 2: 2.0 to 2.9\* Baseline, Grade 3: \>=3.0\* Baseline, or \>=354 umol/L. Baseline was defined as the latest pre-dose assessment. An increase was defined as an increase in grade relative to Baseline grade. Any worst-case post Baseline increase to Grade 1, Grade 2 and Grade 3 are presented.

    Time frame: Baseline (Day 1) and up to 85 days

  5. Number of Participants With Clinically Significant Changes in Clinical Chemistry Results

    Blood samples were collected for analysis of following clinical chemistry parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Calcium, Total and Direct bilirubin, Glucose, Potassium, Sodium, Total protein, Lactate dehydrogenase, Haptoglobins and Urea. Number of participants with clinically significant changes in clinical chemistry were reported. Clinical significance was determined by the investigator.

    Time frame: Up to 85 days

  6. Number of Participants With Worst-case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline

    Urine samples were collected for analysis of Specific gravity, potential of hydrogen (pH), glucose, protein, erythrocytes, ketones, bilirubin, urobilinogen, nitrite, and leukocyte in urine by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Any increase means any increase to trace, 1+, 2+ or 3+ post-Baseline relative to Baseline. Baseline was defined as the latest pre-dose assessment. Number of participants with worst-case any increase in urinalysis results post-Baseline relative to Baseline has been presented.

    Time frame: Baseline (Day 1) and up to 85 days

  7. Number of Participants With Clinically Significant Changes in Vital Sign Results

    Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Clinical significance was determined by the investigator.

    Time frame: Up to 85 days

  8. Number of Participants With Positive Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) and Varicella Zoster Virus (VZV) DNA

    VZV-Nucleic acid from blood samples were extracted using the QIASymphony SP followed by TaqMan real time polymerase chain reaction (PCR) for amplification and detection. Murine cytomegalovirus (mCMV) was used as an internal control (IC) and was introduced during the extraction process. CMV-Nucleic acid was extracted using the QIASymphony SP/AS followed by automated set up of Artus real time PCR using the Rotor-Gene Q for amplification and detection. Baseline was defined as the latest pre-dose assessment. Number of participants with Positive CMV DNA and VZV DNA has been presented.

    Time frame: Baseline (Day 1), Day 15 and Day 85

  9. Number of Participants With Positive Epstein-Barr Virus (EBV) DNA

    EBV DNA was assessed and qualitative data has been presented. Data has been categorized into 'Positive \>=LLQ' and 'Positive \< LLQ'. LLQ is lower limit of quantification. Participants who had EBV DNA values \>=LLQ were categorized as 'Positive \>=LLQ'. This represents a positive result that is above the assay limit of quantification. Participants who had EBV DNA values \<LLQ were categorized as 'Positive \<LLQ'. This represents a positive result that is below the assay limit of quantification. Baseline was defined as the latest pre-dose assessment.

    Time frame: Baseline (Day 1), Day 15 and Day 85

  10. Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings

    Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT corrected interval. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented.

    Time frame: Up to 85 days

Secondary outcomes

  1. Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration

    Blood samples were collected at indicated time points for measurement of serum concentrations of GSK3888130B following intravenous administration. Pharmacokinetic (PK) Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).

    Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

  2. Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration

    Blood samples were collected at indicated time points for measurement of serum concentrations of GSK3888130B following subcutaneous administration.

    Time frame: Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

  3. Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration

    Blood samples were collected at indicated time points for measurement of serum concentrations of GSK3888130B following intravenous administration. Pharmacokinetic (PK) Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).

    Time frame: Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

  4. Area Under the Concentration-time Curve From Time Zero to Time t (AUC[0 to t]) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.

    Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

  5. AUC(0 to t) for Dose Levels 3 and 5 Subcutaneous Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.

    Time frame: Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

  6. AUC(0 to t) for Dose Levels 6 and 7 Intravenous Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.

    Time frame: Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

  7. Maximum Observed Plasma Concentration (Cmax) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.

    Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

  8. Cmax of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.

    Time frame: Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

  9. Cmax of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.

    Time frame: Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

  10. Time to Cmax (Tmax) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.

    Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

  11. Tmax of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.

    Time frame: Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

  12. Tmax of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.

    Time frame: Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

  13. Half-life (t1/2) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.

    Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

  14. t1/2 of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.

    Time frame: Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

  15. t1/2 of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.

    Time frame: Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

  16. Clearance (CL) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.

    Time frame: Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

  17. Clearance Factor (CL/F) of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.

    Time frame: Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

  18. CL of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration

    Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.

    Time frame: Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

  19. Number of Participants With Positive Anti-drug Antibodies Against GSK3888130B

    Serum samples were collected for the determination of anti-drug antibodies (ADA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Baseline was defined as the latest pre-dose assessment.

    Time frame: Baseline (Day 1), Day 15, Day 29, Day 57 and Day 85

  20. Percent Peak Reduction From Baseline in Derived Free Interleukin 7 (IL 7) in Blood

    Free IL-7 levels were derived from total IL-7 and total GSK3888130B concentrations (named as Derived Free IL-7) over time using a nonlinear mixed effects modelling approach. A target-mediated drug disposition model was used to fit the total IL-7 and total GSK3888130B assay concentration data to derive the free-IL-7 concentrations. Peak reduction relative to Baseline (Percent change) was calculated for each participant as; Peak reduction = (1 - minimum \[Free IL7/IL7 Baseline\])\*100. Baseline was defined as the latest pre-dose assessment.

    Time frame: Baseline (Day 1) and up to 8 hours

  21. Median Fluorescence Intensity (MdFI) of B-cell Lymphoma 2 (Bcl-2) Expression in CD4+ T Cells in Blood

    Blood samples were collected at indicated time points to measure Bcl-2 Expression in CD4+ T Cells as median fluorescence intensity (MdFI). Baseline was defined as the latest pre-dose assessment. MdFI values as a measure of Bcl-2 expression in CD4+ T cells was measured by flow cytometry. Placebo arms were combined as pre-specified in reporting and analysis plan.

    Time frame: Baseline (Day 1) and Day 15

07

Results

Posted Mar 26, 2025

Participant flow

Participant flow — Overall Study
MilestonePlaceboGSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 4 IVGSK3888130B Dose Level 5 SCGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
Started153366696
Completed153366696
Not completed00000000

Outcome measures

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

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 any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

Time frame:
Up to 160 days
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
ParticipantsPlaceboGSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 4 IVGSK3888130B Dose Level 5 SCGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
AEs83262485
SAEs00000000
PrimaryNumber of Participants With Clinically Significant Changes in Hematology Results

Blood samples were collected for analysis of following hematology parameters: Basophils, Eosinophils, Hematocrit, Hemoglobin (Hg), Lymphocytes, Mean corpuscular Hg, Mean corpuscular volume, Monocytes, Platelet count, Red blood cell count, Reticulocytes, Total Neutrophils, and White blood cells count (WBC). Number of participants with clinically significant changes in hematology were reported. Clinical significance was determined by the investigator.

Time frame:
Up to 85 days
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Changes in Hematology Results
ParticipantsPlaceboGSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 4 IVGSK3888130B Dose Level 5 SCGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
Number of Participants With Clinically Significant Changes in Hematology Results00000000
PrimaryNumber of Participants With Worst-case Cluster of Differentiation (CD) 4+ T Cell Counts Results by Maximum Grade Increase Post-Baseline Relative to Baseline

Blood samples were collected for the analysis of CD4+ T Cell Counts. The CD4+ T Cell Counts were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE). Grade 0: Above 0.5\*10\^9 cells/Liter (L), Grade 1: \<0.5 to 0.2\*10\^9 cells/L, Grade 2: \<0.2 to 0.05\*10\^9 cells/L, Grade 3: Below 0.05\*10\^9 cells/L. Baseline was defined as the latest pre-dose assessment. An increase was defined as an increase in grade relative to Baseline grade. Any worst-case post Baseline increase to Grade 1, Grade 2 and Grade 3 are presented.

Time frame:
Baseline (Day 1) and up to 85 days
Reported as:
Count of participants · Participants
Number of Participants With Worst-case Cluster of Differentiation (CD) 4+ T Cell Counts Results by Maximum Grade Increase Post-Baseline Relative to Baseline
ParticipantsPlaceboGSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 4 IVGSK3888130B Dose Level 5 SCGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
Increase to Grade 141111354
Increase to Grade 200000000
Increase to Grade 300000000
PrimaryNumber of Participants With Worst-case Creatinine Results by Maximum Grade Increase Post-Baseline Relative to Baseline

Blood samples were collected for the analysis of Creatinine. Creatinine was graded according to the NCI-CTCAE. Grade 0: \<1.5\* Baseline, or increase from Baseline \<26 micromoles per liter (umol/L), Grade 1: 1.5 to 1.9\* Baseline, or increase from Baseline \>=26 umol/L, Grade 2: 2.0 to 2.9\* Baseline, Grade 3: \>=3.0\* Baseline, or \>=354 umol/L. Baseline was defined as the latest pre-dose assessment. An increase was defined as an increase in grade relative to Baseline grade. Any worst-case post Baseline increase to Grade 1, Grade 2 and Grade 3 are presented.

Time frame:
Baseline (Day 1) and up to 85 days
Reported as:
Count of participants · Participants
Number of Participants With Worst-case Creatinine Results by Maximum Grade Increase Post-Baseline Relative to Baseline
ParticipantsPlaceboGSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 4 IVGSK3888130B Dose Level 5 SCGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
Increase to Grade 100000010
Increase to Grade 200000000
Increase to Grade 300000000
PrimaryNumber of Participants With Clinically Significant Changes in Clinical Chemistry Results

Blood samples were collected for analysis of following clinical chemistry parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Calcium, Total and Direct bilirubin, Glucose, Potassium, Sodium, Total protein, Lactate dehydrogenase, Haptoglobins and Urea. Number of participants with clinically significant changes in clinical chemistry were reported. Clinical significance was determined by the investigator.

Time frame:
Up to 85 days
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Changes in Clinical Chemistry Results
ParticipantsPlaceboGSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 4 IVGSK3888130B Dose Level 5 SCGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
Number of Participants With Clinically Significant Changes in Clinical Chemistry Results00000000
PrimaryNumber of Participants With Worst-case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline

Urine samples were collected for analysis of Specific gravity, potential of hydrogen (pH), glucose, protein, erythrocytes, ketones, bilirubin, urobilinogen, nitrite, and leukocyte in urine by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Any increase means any increase to trace, 1+, 2+ or 3+ post-Baseline relative to Baseline. Baseline was defined as the latest pre-dose assessment. Number of participants with worst-case any increase in urinalysis results post-Baseline relative to Baseline has been presented.

Time frame:
Baseline (Day 1) and up to 85 days
Reported as:
Count of participants · Participants
Number of Participants With Worst-case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline
ParticipantsPlaceboGSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 4 IVGSK3888130B Dose Level 5 SCGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
Bilirubin00000000
Erythrocytes00010210
Glucose00010000
Ketones10000001
Leukocytes00000000
Nitrite01000000
Protein00000012
Specific Gravity83245656
Urobilinogen00000000
pH123254685
PrimaryNumber of Participants With Clinically Significant Changes in Vital Sign Results

Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Clinical significance was determined by the investigator.

Time frame:
Up to 85 days
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Changes in Vital Sign Results
ParticipantsPlaceboGSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 4 IVGSK3888130B Dose Level 5 SCGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
Number of Participants With Clinically Significant Changes in Vital Sign Results00000000
PrimaryNumber of Participants With Positive Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) and Varicella Zoster Virus (VZV) DNA

VZV-Nucleic acid from blood samples were extracted using the QIASymphony SP followed by TaqMan real time polymerase chain reaction (PCR) for amplification and detection. Murine cytomegalovirus (mCMV) was used as an internal control (IC) and was introduced during the extraction process. CMV-Nucleic acid was extracted using the QIASymphony SP/AS followed by automated set up of Artus real time PCR using the Rotor-Gene Q for amplification and detection. Baseline was defined as the latest pre-dose assessment. Number of participants with Positive CMV DNA and VZV DNA has been presented.

Time frame:
Baseline (Day 1), Day 15 and Day 85
Reported as:
Count of participants · Participants
Number of Participants With Positive Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) and Varicella Zoster Virus (VZV) DNA
ParticipantsPlaceboGSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 4 IVGSK3888130B Dose Level 5 SCGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
Cytomegalovirus DNA, Baseline (Day 1)00000000
Cytomegalovirus DNA, Day 1500000000
Cytomegalovirus DNA, Day 8500000000
Varicella Zoster Virus DNA, Baseline (Day 1)00000000
Varicella Zoster Virus DNA, Day 1500000000
Varicella Zoster Virus DNA, Day 8500000000
PrimaryNumber of Participants With Positive Epstein-Barr Virus (EBV) DNA

EBV DNA was assessed and qualitative data has been presented. Data has been categorized into 'Positive \>=LLQ' and 'Positive \< LLQ'. LLQ is lower limit of quantification. Participants who had EBV DNA values \>=LLQ were categorized as 'Positive \>=LLQ'. This represents a positive result that is above the assay limit of quantification. Participants who had EBV DNA values \<LLQ were categorized as 'Positive \<LLQ'. This represents a positive result that is below the assay limit of quantification. Baseline was defined as the latest pre-dose assessment.

Time frame:
Baseline (Day 1), Day 15 and Day 85
Reported as:
Count of participants · Participants
Number of Participants With Positive Epstein-Barr Virus (EBV) DNA
ParticipantsPlaceboGSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 4 IVGSK3888130B Dose Level 5 SCGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
Baseline (Day 1), Positive < LLQ01000101
Baseline (Day 1), Positive >= LLQ20010002
Day 15, Positive < LLQ00001021
Day 15, Positive >= LLQ00000010
Day 85, Positive < LLQ00000000
Day 85, Positive >= LLQ11001001
PrimaryNumber of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings

Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT corrected interval. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented.

Time frame:
Up to 85 days
Reported as:
Count of participants · Participants
Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings
ParticipantsPlaceboGSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 4 IVGSK3888130B Dose Level 5 SCGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
CLINICALLY SIGNIFICANT00000000
NOT CLINICALLY SIGNIFICANT121264675
SecondarySerum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration

Blood samples were collected at indicated time points for measurement of serum concentrations of GSK3888130B following intravenous administration. Pharmacokinetic (PK) Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).

Time frame:
Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Reported as:
Geometric mean · Nanograms per milliliter (ng/mL)
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
Nanograms per milliliter (ng/mL)GSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 4 IV
DAY 1 (Pre-dose)NA (NA to NA)NA (NA to NA)NA (NA to NA)
DAY 1 (15 Minutes)363.2 (196.7 to 670.9)2155.9 (1003.0 to 4634.4)15901.1 (13993.4 to 18069.0)
DAY 1 (30 Minutes)893.1 (504.7 to 1580.5)4717.5 (3173.3 to 7013.1)35633.0 (30628.5 to 41455.2)
DAY 1 (4 Hours)761.4 (677.2 to 856.1)4497.0 (2542.8 to 7953.0)32762.8 (28319.4 to 37903.3)
DAY 1 (8 Hours)753.5 (483.7 to 1173.8)3964.2 (1974.7 to 7958.0)31180.8 (27855.3 to 34903.4)
DAY 1 (12 Hours)758.1 (601.3 to 955.8)3599.9 (2601.7 to 4981.2)29821.8 (26986.2 to 32955.3)
DAY 1 (24 Hours)720.8 (558.6 to 930.0)3781.5 (2095.7 to 6823.7)28096.6 (26173.0 to 30161.6)
DAY 1 (48 Hours)572.8 (401.3 to 817.7)3184.0 (2280.6 to 4445.1)23358.3 (20418.2 to 26721.8)
DAY 6NA (NA to NA)2134.0 (1229.6 to 3703.5)15978.7 (14176.6 to 18009.9)
DAY 8NA (NA to NA)1862.5 (883.6 to 3926.1)14071.9 (13088.2 to 15129.5)
DAY 10NA (NA to NA)1850.1 (928.4 to 3687.1)12873.0 (11718.1 to 14141.7)
DAY 15NA (NA to NA)1539.6 (740.1 to 3202.8)10293.7 (9018.8 to 11748.8)
DAY 21NA (NA to NA)1263.0 (416.5 to 3829.5)8485.9 (7647.8 to 9415.9)
DAY 29NA (NA to NA)1027.3 (404.7 to 2607.4)6904.9 (5741.6 to 8304.0)
DAY 57NA (NA to NA)625.4 (192.9 to 2027.2)3545.2 (2721.4 to 4618.4)
DAY 85NA (NA to NA)NA (NA to NA)1797.5 (1152.8 to 2802.8)
SecondarySerum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration

Blood samples were collected at indicated time points for measurement of serum concentrations of GSK3888130B following subcutaneous administration.

Time frame:
Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Reported as:
Geometric mean · ng/mL
Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
ng/mLGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 5 SC
DAY 1 (Pre-dose)NA (NA to NA)NA (NA to NA)
DAY 1 (4 Hours)NA (NA to NA)2540.4 (1193.5 to 5407.6)
DAY 1 (8 Hours)NA (NA to NA)5287.2 (2659.9 to 10509.8)
DAY 1 (12 Hours)NA (NA to NA)8236.8 (4122.6 to 16456.5)
DAY 1 (24 Hours)1284.2 (795.2 to 2073.7)14161.9 (7502.7 to 26731.7)
DAY 1 (48 Hours)2297.0 (1506.7 to 3501.9)23239.0 (12191.4 to 44297.5)
DAY 63253.7 (2339.4 to 4525.5)34612.8 (25180.0 to 47579.2)
DAY 83327.1 (2422.0 to 4570.5)34801.7 (25828.6 to 46892.0)
DAY 103078.4 (2316.4 to 4091.2)33654.8 (25702.9 to 44066.9)
DAY 152814.4 (2172.0 to 3646.8)29870.9 (22782.2 to 39165.2)
DAY 212856.1 (2199.3 to 3709.1)27433.3 (21634.8 to 34785.7)
DAY 292266.1 (1614.4 to 3181.0)21108.5 (16241.6 to 27434.0)
DAY 571288.8 (817.0 to 2032.9)11567.5 (7780.8 to 17197.0)
DAY 85NA (NA to NA)5780.9 (3113.3 to 10733.9)
SecondarySerum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration

Blood samples were collected at indicated time points for measurement of serum concentrations of GSK3888130B following intravenous administration. Pharmacokinetic (PK) Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).

Time frame:
Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Reported as:
Geometric mean · ng/mL
Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration
ng/mLGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
DAY 1 (Pre-dose)NA (NA to NA)NA (NA to NA)
DAY 1 (30 Minutes)201271.5 (162241.9 to 249690.2)446824.2 (396812.5 to 503139.1)
DAY 1 (1 Hour)365002.7 (300217.9 to 443767.6)887258.7 (772728.3 to 1018764.4)
DAY 1 (4 Hours)334755.7 (275365.5 to 406955.0)845654.2 (743870.4 to 961365.0)
DAY 1 (8 Hours)333669.5 (254377.8 to 437677.0)839439.2 (725811.5 to 970855.7)
DAY 1 (12 Hours)312692.1 (251461.1 to 388832.9)738220.9 (642655.8 to 847997.0)
DAY 1 (24 Hours)288550.5 (235725.2 to 353213.8)744312.7 (631579.3 to 877168.5)
DAY 1 (48 Hours)221884.4 (173674.6 to 283476.6)595269.2 (525651.3 to 674107.3)
DAY 6186043.0 (154906.8 to 223437.5)432475.7 (378277.5 to 494439.2)
DAY 8148716.7 (122678.0 to 180282.2)362540.8 (282254.6 to 465664.2)
DAY 10150354.6 (119156.0 to 189722.0)361427.9 (295704.5 to 441759.0)
DAY 15124163.7 (104218.9 to 147925.3)311912.7 (254633.2 to 382077.2)
DAY 21108208.1 (95733.2 to 122308.5)259786.4 (206492.4 to 326835.0)
DAY 2988424.1 (81046.3 to 96473.4)207998.2 (147558.4 to 293194.2)
DAY 5734733.0 (24307.2 to 49630.7)100288.2 (65503.1 to 153545.9)
DAY 8516634.1 (12462.7 to 22201.9)53029.2 (34299.5 to 81986.7)
SecondaryArea Under the Concentration-time Curve From Time Zero to Time t (AUC[0 to t]) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.

Time frame:
Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Reported as:
Geometric mean · Hours*micrograms per milliliter(h*ug/mL)
Area Under the Concentration-time Curve From Time Zero to Time t (AUC[0 to t]) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
Hours*micrograms per milliliter(h*ug/mL)GSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 4 IV
Area Under the Concentration-time Curve From Time Zero to Time t (AUC[0 to t]) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration65.81 ± 75.501837.01 ± 48.8613524.34 ± 16.29
SecondaryAUC(0 to t) for Dose Levels 3 and 5 Subcutaneous Administration

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.

Time frame:
Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Reported as:
Geometric mean · h*ug/mL
AUC(0 to t) for Dose Levels 3 and 5 Subcutaneous Administration
h*ug/mLGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 5 SC
AUC(0 to t) for Dose Levels 3 and 5 Subcutaneous Administration3550.71 ± 38.6335669.70 ± 25.35
SecondaryAUC(0 to t) for Dose Levels 6 and 7 Intravenous Administration

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.

Time frame:
Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Reported as:
Geometric mean · h*ug/mL
AUC(0 to t) for Dose Levels 6 and 7 Intravenous Administration
h*ug/mLGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
AUC(0 to t) for Dose Levels 6 and 7 Intravenous Administration153885.4 ± 12.54387454.3 ± 24.96
SecondaryMaximum Observed Plasma Concentration (Cmax) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.

Time frame:
Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Reported as:
Geometric mean · Micrograms per milliliter (ug/mL)
Maximum Observed Plasma Concentration (Cmax) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
Micrograms per milliliter (ug/mL)GSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 4 IV
Maximum Observed Plasma Concentration (Cmax) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration0.9034 ± 21.57074.8156 ± 18.706935.6330 ± 14.4965
SecondaryCmax of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.

Time frame:
Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Reported as:
Geometric mean · ug/mL
Cmax of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
ug/mLGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 5 SC
Cmax of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration3.4609 ± 31.262436.3795 ± 24.9230
SecondaryCmax of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.

Time frame:
Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Reported as:
Geometric mean · ug/mL
Cmax of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration
ug/mLGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
Cmax of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration386.4759 ± 29.7837907.7045 ± 11.2907
SecondaryTime to Cmax (Tmax) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.

Time frame:
Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Reported as:
Median · Hour
Time to Cmax (Tmax) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
HourGSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 4 IV
Time to Cmax (Tmax) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration0.583 (0.55 to 4.00)0.550 (0.55 to 4.00)0.558 (0.55 to 0.58)
SecondaryTmax of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.

Time frame:
Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Reported as:
Median · Hour
Tmax of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
HourGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 5 SC
Tmax of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration168.000 (120.00 to 222.12)143.475 (120.00 to 240.95)
SecondaryTmax of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.

Time frame:
Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Reported as:
Median · Hour
Tmax of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration
HourGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
Tmax of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration1.083 (1.05 to 24.00)2.533 (1.05 to 8.00)
SecondaryHalf-life (t1/2) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.

Time frame:
Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Reported as:
Geometric mean · Hour
Half-life (t1/2) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
HourGSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 4 IV
Half-life (t1/2) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration123.73 ± 35.44633.05 ± 32.53627.11 ± 17.66
Secondaryt1/2 of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.

Time frame:
Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Reported as:
Geometric mean · Hour
t1/2 of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
HourGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 5 SC
t1/2 of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration784.05 ± 13.62749.02 ± 31.55
Secondaryt1/2 of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.

Time frame:
Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Reported as:
Geometric mean · Hour
t1/2 of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration
HourGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
t1/2 of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration563.53 ± 22.12628.91 ± 13.71
SecondaryClearance (CL) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.

Time frame:
Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Reported as:
Geometric mean · Milliliter per hour (mL/h)
Clearance (CL) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
Milliliter per hour (mL/h)GSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 4 IV
Clearance (CL) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration21.501 ± 38.1384.240 ± 52.7826.542 ± 22.034
SecondaryClearance Factor (CL/F) of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.

Time frame:
Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Reported as:
Geometric mean · mL/h
Clearance Factor (CL/F) of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
mL/hGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 5 SC
Clearance Factor (CL/F) of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration9.149 ± 36.8109.297 ± 27.211
SecondaryCL of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.

Time frame:
Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Reported as:
Geometric mean · mL/h
CL of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration
mL/hGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
CL of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration5.920 ± 11.5486.860 ± 28.592
SecondaryNumber of Participants With Positive Anti-drug Antibodies Against GSK3888130B

Serum samples were collected for the determination of anti-drug antibodies (ADA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Baseline was defined as the latest pre-dose assessment.

Time frame:
Baseline (Day 1), Day 15, Day 29, Day 57 and Day 85
Reported as:
Count of participants · Participants
Number of Participants With Positive Anti-drug Antibodies Against GSK3888130B
ParticipantsPlaceboGSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 4 IVGSK3888130B Dose Level 5 SCGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
Baseline (Day 1)00001000
Day 1500001000
Day 2900001000
Day 5700001000
Day 8500001000
SecondaryPercent Peak Reduction From Baseline in Derived Free Interleukin 7 (IL 7) in Blood

Free IL-7 levels were derived from total IL-7 and total GSK3888130B concentrations (named as Derived Free IL-7) over time using a nonlinear mixed effects modelling approach. A target-mediated drug disposition model was used to fit the total IL-7 and total GSK3888130B assay concentration data to derive the free-IL-7 concentrations. Peak reduction relative to Baseline (Percent change) was calculated for each participant as; Peak reduction = (1 - minimum \[Free IL7/IL7 Baseline\])\*100. Baseline was defined as the latest pre-dose assessment.

Time frame:
Baseline (Day 1) and up to 8 hours
Reported as:
Mean · Percent Change
Percent Peak Reduction From Baseline in Derived Free Interleukin 7 (IL 7) in Blood
Percent ChangePlaceboGSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 4 IVGSK3888130B Dose Level 5 SCGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
Percent Peak Reduction From Baseline in Derived Free Interleukin 7 (IL 7) in Blood0.0 ± 0.0095.8 ± 1.538399.1 ± 0.284190.3 ± 4.231199.9 ± 0.024698.6 ± 0.8138100 ± 0.0025100 ± 0.0004
SecondaryMedian Fluorescence Intensity (MdFI) of B-cell Lymphoma 2 (Bcl-2) Expression in CD4+ T Cells in Blood

Blood samples were collected at indicated time points to measure Bcl-2 Expression in CD4+ T Cells as median fluorescence intensity (MdFI). Baseline was defined as the latest pre-dose assessment. MdFI values as a measure of Bcl-2 expression in CD4+ T cells was measured by flow cytometry. Placebo arms were combined as pre-specified in reporting and analysis plan.

Time frame:
Baseline (Day 1) and Day 15
Reported as:
Median · Median fluorescence intensity
Median Fluorescence Intensity (MdFI) of B-cell Lymphoma 2 (Bcl-2) Expression in CD4+ T Cells in Blood
Median fluorescence intensityPlaceboGSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 4 IVGSK3888130B Dose Level 5 SCGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
Baseline (Day 1)92427.0 (55433 to 114550)64576.0 (47010 to 82059)68096.0 (54750 to 72379)92724.0 (64251 to 104760)73182.5 (66900 to 93636)93540.5 (79770 to 108965)90059.0 (71281 to 118233)101786.0 (101255 to 120759)
Day 1588899.0 (62339 to 128682)79882.5 (65395 to 94370)75396.0 (53411 to 77550)62436.5 (32520 to 77948)52592.0 (50096 to 67410)55938.5 (26200 to 63447)50715.0 (40283 to 65395)58098.5 (49364 to 69492)

Adverse events

Collected over All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/15 (0%)0/15 (0%)8/15 (53.3%)
GSK3888130B Dose Level 1 IV0/3 (0%)0/3 (0%)3/3 (100%)
GSK3888130B Dose Level 2 IV0/3 (0%)0/3 (0%)2/3 (66.7%)
GSK3888130B Dose Level 3 SC0/6 (0%)0/6 (0%)6/6 (100%)
GSK3888130B Dose Level 4 IV0/6 (0%)0/6 (0%)2/6 (33.3%)
GSK3888130B Dose Level 5 SC0/6 (0%)0/6 (0%)4/6 (66.7%)
GSK3888130B Dose Level 6 IV0/9 (0%)0/9 (0%)8/9 (88.9%)
GSK3888130B Dose Level 7 IV0/6 (0%)0/6 (0%)5/6 (83.3%)
Most frequent other events
Showing 10 of 45
Most frequent other events
EventPlaceboGSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 4 IVGSK3888130B Dose Level 5 SCGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IV
COVID-19Infections and infestations3/152/31/30/61/61/61/90/6
NasopharyngitisInfections and infestations1/150/32/30/60/60/63/90/6
HypertransaminasaemiaHepatobiliary disorders0/150/30/30/60/62/61/90/6
Infected cystInfections and infestations0/151/30/30/60/60/60/90/6
ContusionInjury, poisoning and procedural complications1/151/30/30/60/60/60/91/6
HeadacheNervous system disorders3/151/30/31/60/61/62/91/6
Dermatitis contactSkin and subcutaneous tissue disorders1/150/31/30/60/60/62/92/6
Ear painEar and labyrinth disorders0/150/30/31/60/60/60/90/6
Gastrooesophageal reflux diseaseGastrointestinal disorders0/150/30/30/60/60/60/91/6
Catheter site rashGeneral disorders0/150/30/30/61/60/60/90/6

Baseline characteristics

Placebo arms were combined as pre-specified in reporting and analysis plan.

Age, Continuous
Age, Continuous(YEARS)PlaceboGSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 4 IVGSK3888130B Dose Level 5 SCGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IVTotal
Mean40.3 ± 8.9340.0 ± 7.9448.3 ± 3.0638.8 ± 8.7541.2 ± 9.5240.8 ± 7.7038.7 ± 9.8641.5 ± 11.5740.6 ± 8.78
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboGSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 4 IVGSK3888130B Dose Level 5 SCGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IVTotal
Female000000000
Male15336669654
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboGSK3888130B Dose Level 1 IVGSK3888130B Dose Level 2 IVGSK3888130B Dose Level 3 SCGSK3888130B Dose Level 4 IVGSK3888130B Dose Level 5 SCGSK3888130B Dose Level 6 IVGSK3888130B Dose Level 7 IVTotal
All Other Races15336669654
08

Study locations

1 site
  • GSK Investigational Site
    Cambridge, CB2 2GG, United Kingdom
09

References and documents

Study documents

  • Study protocol · Mar 21, 2023
  • Statistical analysis plan · Aug 17, 2023

Documents are hosted by the registry — open the source record to download them.

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, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05131971
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Nov 23, 2021
Start date
Nov 1, 2021
Primary completion
Oct 12, 2023
Completion
Oct 12, 2023
Results posted
Mar 26, 2025
Last update
Mar 26, 2025

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 Mar 2025. You cannot join it, but the record below documents what was studied.

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