A Study of GSK4771261 in Healthy Participants Aged 25 to 55 Years of Age Inclusive (NCT07600450) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of GSK4771261 in Healthy Participants Aged 25 to 55 Years of Age Inclusive
30 participantsStarted 2026-05-15
Plain-language summary
This is a first time in Asia (FTIA) study of GSK4771261 in healthy participants of Chinese, Japanese, and White/European ancestry. The study will test whether GSK4771261 is safe, well-tolerated, how it is processed in the body, and whether it triggers an immune response.
Who can participate
Age range
25 Years – 55 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:
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests. A participant with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the normal reference range for the population being studied may be included only if the Investigator, in their clinical judgement, believes and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
* Body weight at least 50.0 kilograms (kg) for male participants or at least 45.0 kg for female participants at screening
* Body Mass Index (BMI) within the range of 18.0 - 28.0 kilogram per square meters (kg/m\^2) (inclusive) at screening
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and is a Participant of non-childbearing potential (PONCBP)
* Capable of giving signed informed consent
* Participants of Chinese ancestry or Japanese ancestry or White/European ancestry are eligible based on meeting all the following criteria:
* Participants of Chinese ancestry: Born in mainland China, Hong Kong, or Taiwan; descendant of 4 ethnic Chinese grandparents and 2 ethnic Chinese parents; and have lived outside mainland China, Hong Kong, or Taiwan for less than 10 years at the time of screening
* Participants of Japanese ancestry: born in Japan; descendant of 4 e…
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
1
Number of Participants with Adverse Events (AEs), Injection Site Reactions, and Serious AEs (SAEs)
Timeframe: Up to Week 13 (End of Study)
2
Number of Participants with Clinically Significant Changes from Baseline in Vital Signs
Timeframe: Up to Week 13 (End of Study)
3
Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Values
Timeframe: Up to Week 13 (End of Study)
4
Number of Participants with Clinically Significant Changes from Baseline in 12-Lead Electrocardiogram (ECG)
Timeframe: Up to Week 13 (End of Study)
5
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-t])
Timeframe: Up to Week 13
6
Area under the serum concentration-time curve extrapolated to infinite time (AUC[0-inf])