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RecruitingNCT07646353Updated Oct 5, 2026

First-in-Human Dose-escalation of GSK4425689A: Safety, Tolerability, and PK in Healthy Adults

A Phase 1 interventional study of GSK4425689A SC and GSK4425689A IV in Malaria, Falciparum, sponsored by GlaxoSmithKline. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Prevention

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Updated Oct 5, 2026Now RecruitingFirst site in United Kingdom+4 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study will assess the safety, tolerability, and pharmacokinetic properties of GSK4425689A monoclonal antibody (mAb) in healthy adults, when administered by either intravenous (IV) or subcutaneous (SC) routes.

02

Conditions studied

  • Malaria, Falciparum

Keywords

  • Malaria
  • GSK4425689A
  • First-in-human
  • Safety
  • Tolerability
  • Pharmacokinetic
  • Healthy Adults
  • Dose escalation
  • Monoclonal antibody (mAb)
03

In context

Malaria, Falciparum

455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.

This study's planned enrollment of 40 is below the median of 126 across 376 interventional studies indexed under Malaria, Falciparum.

Browse Malaria, Falciparum studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.

Browse GlaxoSmithKline studies →

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  1. Participants must be 18 to 65 years of age inclusive, at the time of signing the .
  2. Participants must have a body weight between 50 and 100 kg, inclusive and body-mass index () within the range of 18.0 to 32.0 kg/m\^2.
  3. Participants must be healthy male or female participant of non- (PONCBP).
  4. Participants must be capable of giving signed informed consent prior to any study-specific procedures, which include compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  5. Participants must demonstrate the ability to understand and comply with the study requirements, including attendance for all scheduled visits and adherence to protocol-specified procedures and restrictions. Participants must be willing to remain in close contact with study personnel and reliably record data as instructed.
  6. Participants must be in good general health and have no significant ongoing medical conditions, as determined by comprehensive medical history, thorough physical examination, vital signs assessment, 12-lead , and clinical laboratory evaluations (including hematology, biochemistry, and urinalysis).
  7. Participants should have baseline (screening) clinical laboratory values (renal, hepatic, and hematological) within normal limits or clinically acceptable to the investigator. A participant with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, or outside the normal reference range for the population being studied, may be included only if the investigator considers that the finding is unlikely to introduce additional risk factors for the participant and will not interfere with the study procedures or endpoints.
  8. Serum (ALT), aspartate aminotransferase (AST), and total levels must be within the normal range at Screening.

Exclusion criteria

Exclusion Criteria:

  1. Participants with a history of malaria infection or who have previously participated in malaria vaccine trials or studies involving experimental anti-malarial monoclonals, small molecule drugs, or experimental malaria challenge are excluded. Participants who have been vaccinated against malaria with an or approved vaccine (e.g., RTS,S and R21/Matrix-M) are excluded.
  2. History of allergy to humanized monoclonal antibodies (mAbs) or constituents of the formulation.
  3. Any history of anaphylaxis or other severe allergic reactions, or food, or drug allergy that may impact participant safety in the opinion of the investigator.
  4. Recent history of, or presence of a current or suspected chronic disease that may impact participant safety, or impact interpretation of clinical study results. This includes illnesses such as (but not limited to) cardiac disease, disease, diabetes, progressive neurological disease, severe malnutrition, hepatic or renal disease, epilepsy, or asthma (except resolved childhood asthma, which is acceptable). Conditions that in the opinion of the investigator constitute a risk to the individual when taking the study intervention or likely to interfere with the interpretation of data.
  5. Have a history of malignant neoplasm (other than localized basal or squamous cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within 5 years of Screening, regardless of whether there is evidence of local recurrence or .
  6. Current enrolment or participation in another clinical study.
  7. Participation in another clinical study involving any investigational product within the past 90 days or within a period equivalent to 5 half-lives of the investigational drug, whichever is longer, or receipt of experimental non-malaria vaccines or mAbs within the past 12 months prior to signing the .
  8. corrected for heart rate by Fridericia's formula (QTcF) >450 msec.
  9. Presence or history of cardiac arrhythmias or cardiac disease or a family or personal history of long-QT syndrome.
  10. Average heart rate of \<40 or >100 beats per minute (bpm).
  11. Evidence of previous myocardial infarction or any conduction abnormality such as left bundle branch block, atrioventricular (AV) block (2nd degree or higher), Wolff-Parkinson-White syndrome, atrial fibrillation, and atrial flutter. A long-standing right bundle branch block is permitted.
  12. Participants cannot take investigational product with biologic agents (such as mAbs including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to signing the informed consent.
  13. Past or intended use of over the counter or prescription medication, including herbal medications or cannabidiol (CBD)-based products within 14 days prior to administration of study intervention.

  14. Recent infection or illness:

    • Participants with any acute illness or infection requiring treatment within 28 days prior to Screening are excluded (but may be re-screened if appropriate).
    • Participants with evidence of active infections, such as Coronavirus disease 2019 (COVID-19) or tuberculosis are excluded.
  15. Participants who have received any within 3 months prior to Screening or plan to receive such vaccines during the clinical study.
  16. Positive drug screen at Screening, including tetrahydrocannabinol, indicating use of known recreational drugs or drugs of abuse.
  17. An average weekly alcohol intake of >21 units per week for male participants and >14 units per week for female participants within 6 months prior to Screening. One unit is equivalent to 8 g of alcohol: a half-pint (\~240 mL) of beer, 1 glass (125 mL) of wine, or 1 (25 mL) measure of spirits.
  18. Any individual who is a current smoker or has a history of cigarette smoking of more than 5 pack years or regular use of tobacco- or nicotine-containing products within 6 months prior to Screening (including e-cigarettes or vaping).

  19. Pregnancy and lactation:

    • Participants of (POCBP) are excluded.
    • Pregnant or breastfeeding females are excluded.
  20. Participants who have donated 500 mL or more of blood or blood products within 12 weeks before administration of study intervention are excluded.

  21. Concomitant conditions:

    • Positive (HIV) antibody test.
  22. Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for clinically established Gilbert's syndrome or asymptomatic gallstones).
  23. Presence of surface antigen (HBsAg) at Screening or within 3 months prior to first dose of study intervention.
  24. Positive antibody test result at Screening or within 3 months prior to first dose of study intervention.
  25. Positive hepatitis C RNA test result at Screening or within 3 months prior to first dose of study intervention.
  26. History of severe reactions to IV or SC injections (e.g., anaphylaxis, vasovagal syncope).
Terms in these criteria, in plain language(16)

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.

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.

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.

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.

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.

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.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

COPD

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

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

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.

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.

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.

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.

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.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    GSK4425689A Low Dose SC Group

    Participants receive a low dose of GSK4425689A subcutaneously (SC) on Day 1.

    Biological: GSK4425689A SC · Drug: Placebo

  • Experimental
    GSK4425689A Low Dose IV Group

    Participants receive a low dose of GSK4425689A intravenously (IV) on Day 1.

    Biological: GSK4425689A IV · Drug: Placebo

  • Experimental
    GSK4425689A Medium Dose SC Group

    Participants receive a medium dose of GSK4425689A SC on Day 1.

    Biological: GSK4425689A SC · Drug: Placebo

  • Experimental
    GSK4425689A Medium Dose IV Group

    Participants receive a medium dose of GSK4425689A IV on Day 1.

    Biological: GSK4425689A IV · Drug: Placebo

  • Experimental
    GSK4425689A High Dose IV Group

    Participants receive a high dose of GSK4425689A IV on Day 1.

    Biological: GSK4425689A IV · Drug: Placebo

Interventions

  • BiologicalGSK4425689A SC

    Participants receive GSK4425689A SC.

  • BiologicalGSK4425689A IV

    Participants receive GSK4425689A IV.

  • DrugPlacebo

    Participants receive Placebo in the same volume and route as the participants receiving GSK4425689A in the same cohort.

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events (AEs) overall and by severity

    An AE is defined as 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. Grades are defined based on numeric criteria as follows Grade 1: mild; Grade 2: moderate; Grade 3: severe. Higher grades indicate greater severity.

    Time frame: From Day 1 up to Day 364

  2. Number of participants with serious adverse events (SAEs) overall and by severity

    An SAE is defined as any untoward medical . occurrence that results in death, is life- . threatening, requires inpatient hospitalization or extends existing hospitalization, causes . persistent or significant disability/incapacity, involves a congenital anomaly/birth defect in a participants offspring, includes an abnormal . pregnancy outcome, or occurs in any other . situation per the investigators judgement. Grades are defined based on numeric criteria as follows Grade 1: mild; Grade 2: moderate; Grade 3: severe. Higher grades indicate greater severity.

    Time frame: From Day -28 [informed consent form (ICF) signing] up to Day 364

Secondary outcomes

  1. Bioavailability (F) of SC administration

    Time frame: From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose

  2. Terminal serum half-life (t1/2)

    Time frame: From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose

  3. Clearance (CL) of IV administration and apparent clearance (CL/F) of SC administration

    Time frame: From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose

  4. Volume of distribution (Vd) of IV administration and apparent volume of distribution (Vd/F) of SC administration

    Time frame: From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose

  5. Maximum observed serum concentration (Cmax)

    Time frame: From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose

  6. Time to reach Cmax (Tmax)

    Time frame: From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose

  7. Area under the serum concentration-time curve (AUC) from time zero up to 168 hours (AUC0-168)

    Time frame: From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose

  8. AUC0-672

    Time frame: From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504 and 672 hours post-dose

  9. AUC from time zero up to the time of the last quantifiable sample (AUC0-t)

    Time frame: From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose

  10. AUC extrapolated to infinity (AUC0-inf)

    Time frame: From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose

  11. Dose proportionality of Cmax following IV administration

    Time frame: From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approx. 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose

  12. Dose proportionality of AUC0-t following IV administration

    Time frame: From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approx. 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose

  13. Dose proportionality of AUC0-inf following IV administration

    Time frame: From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approx. 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose

07

Study locations

1 of 1 sites recruiting
  • GSK Investigational Site
    Manchester, M23 9QZ, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

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

Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.

Data sharing details ↗ · www.gsk-studyregister.com

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar 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

Started Jul 2026 (actual). Primary completion is estimated for Apr 2028, 20 months after the start.

Of 49 phase 1 interventional studies under Malaria, Falciparum, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 18. This study's planned 20 months is above that.

Start moved once since we started tracking on Sep 25, 2026: Jun 2026 → Jul 2026, on Oct 5, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

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

Registered
Jun 9, 2026
First posted
Jun 12, 2026
StartActual
Jul 27, 2026was Jun 2026
Primary completionEst.
Apr 10, 2028
CompletionEst.
Apr 10, 2028
Last update
Oct 5, 2026
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.
Status
Not yet recruiting→Recruiting
changed Oct 5, 2026
Sites
1 site added — first site in United Kingdom
Show site
  • GSK Investigational Site · Manchester, United Kingdom
Oct 5, 2026
Start date
Jun 12, 2026→Jul 27, 2026 (actual)
Oct 5, 2026
Primary completion
Apr 19, 2028→Apr 10, 2028
Oct 5, 2026
Study completion
Apr 19, 2028→Apr 10, 2028
Oct 5, 2026
Secondary outcomes
13 time frame changed
What changed in the outcomes
  • Time frameBioavailability (F) of SC administrationFrom Day 1 until Day 197 [samples taken at pre-dose (within 1 hour (h)) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
  • Time frameTerminal serum half-life (t1/2)From Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
  • Time frameClearance (CL) of IV administration and apparent clearance (CL/F) of SC administrationFrom Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
  • Time frameVolume of distribution (Vd) of IV administration and apparent volume of distribution (Vd/F) of SC administrationFrom Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
  • Time frameMaximum observed serum concentration (Cmax)From Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
  • Time frameTime to reach Cmax (Tmax)From Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
  • Time frameArea under the serum concentration-time curve (AUC) from time zero up to 168 hours (AUC0-168)From Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approximately 4, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose
  • Time frameAUC0-672From Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504 and 672 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504 and 672 hours post-dose
  • Time frameAUC from time zero up to the time of the last quantifiable sample (AUC0-t)From Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
  • Time frameAUC extrapolated to infinity (AUC0-inf)From Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
  • Time frameDose proportionality of Cmax following IV administrationFrom Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approx. 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approx. 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
  • Time frameDose proportionality of AUC0-t following IV administrationFrom Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approx. 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approx. 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
  • Time frameDose proportionality of AUC0-inf following IV administrationFrom Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approx. 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approx. 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in United Kingdom
    Show site
    • GSK Investigational Site · Manchester, United Kingdom
    Start date Jun 12, 2026→Jul 27, 2026 (now actual)
    Primary completion Apr 19, 2028→Apr 10, 2028
    Study completion Apr 19, 2028→Apr 10, 2028
    Secondary outcomes 13 time frame changed
    What changed in the outcomes
    • Time frameBioavailability (F) of SC administrationFrom Day 1 until Day 197 [samples taken at pre-dose (within 1 hour (h)) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
    • Time frameTerminal serum half-life (t1/2)From Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
    • Time frameClearance (CL) of IV administration and apparent clearance (CL/F) of SC administrationFrom Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
    • Time frameVolume of distribution (Vd) of IV administration and apparent volume of distribution (Vd/F) of SC administrationFrom Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
    • Time frameMaximum observed serum concentration (Cmax)From Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
    • Time frameTime to reach Cmax (Tmax)From Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
    • Time frameArea under the serum concentration-time curve (AUC) from time zero up to 168 hours (AUC0-168)From Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approximately 4, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose
    • Time frameAUC0-672From Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504 and 672 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504 and 672 hours post-dose
    • Time frameAUC from time zero up to the time of the last quantifiable sample (AUC0-t)From Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
    • Time frameAUC extrapolated to infinity (AUC0-inf)From Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approximately 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
    • Time frameDose proportionality of Cmax following IV administrationFrom Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approx. 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approx. 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
    • Time frameDose proportionality of AUC0-t following IV administrationFrom Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approx. 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approx. 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
    • Time frameDose proportionality of AUC0-inf following IV administrationFrom Day 1 until Day 197 [samples taken at pre-dose (within 1h) and at approx. 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose → From Day 1 until Day 197 [samples taken at pre-dose (within 1 hour) and at approx. 4, 8, 12, 24, 48, 72, 96, 120, 168, 336, 504, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose
    + 2 other changes: verification date and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07646353
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jun 12, 2026
Start date
Jul 27, 2026
Primary completion
Apr 10, 2028 (estimated)
Completion
Apr 10, 2028 (estimated)
Last update
Oct 5, 2026

Study contacts

US GSK Clinical Trials Call Center
Contact
GSKClinicalSupportHD@gsk.com
877-379-3718
EU GSK Clinical Trials Call Center
Contact
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466

Oversight

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

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