CompletedPhase 1

Study of GSK3511294 in Healthy Chinese Participants

China20 participantsStarted 2021-12-10

Plain-language summary

This single dose pharmacokinetic (PK) study aims to investigate the PK, safety, tolerability and immunogenicity of two dose levels of GSK3511294 administered subcutaneously in Chinese healthy participants

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participant between 18 to 45 years of age. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiograms and vital signs. * Body weight greater than or equal to (\>=)50.0 kilograms (kg) for males, \>=45.0 kg for females, and body mass index (BMI) within the range (19.0-26.0) kg/meter square (m\^2) (inclusive). * Contraceptive use by men and/or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Capable of giving signed informed consent. Exclusion Criteria: * Participant is pregnant, breastfeeding, or a woman of childbearing potential * History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs * Participants with allergy/intolerance to a monoclonal antibody or biologic or participants with a previous history of clinically significant multiple or severe allergic reactions/intolerance * Current evidence or recent history of an infective illness * A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse * Clinically significant abnormalities * Participants with Coronavirus Disease-2019 (COVID-19) * With prior/concurrent clinical study experience.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero (Pre-Dose) Extrapolated to Infinite Time (AUC[0-Infinity]) of Depemokimab

Timeframe: Day 1 (Pre-dose, 2h, and 8h Post-dose), Day 2, Day 3, Day 5, Day 8, Day 15, Day 29, Day 57, Day 85, Day 127, Day 169, and Day 183

AUC From Time 0 (Pre-Dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC[0-T]) of Depemokimab

Timeframe: Day 1 (Pre-dose, 2h, and 8h Post-dose), Day 2, Day 3, Day 5, Day 8, Day 15, Day 29, Day 57, Day 85, Day 127, Day 169, and Day 183

AUC From Time 0 (Pre-dose) to Week 4 (AUC[0-Week 4]) of Depemokimab

Timeframe: Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, and 29

AUC From Time 0 (Pre-dose) To Week 12 (AUC[0-Week 12]) Of Depemokimab

Timeframe: Pre-dose (Day 1); 2 h, 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, and 85

AUC From Time 0 (Pre-dose) To Week 26 [AUC(0-Week 26)] of Depemokimab

Timeframe: Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183

Percentage Of AUC(0-Infinity) Obtained by Extrapolation (%AUCex) of Depemokimab

Trial details

NCT IDNCT05140200

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-23

Results submitted2026-04-10

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