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Recruiting Phase 1 NCT06681181

A First-time in Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK4528287 in Healthy Participants

Trial Parameters

Condition Colitis, Ulcerative
Sponsor GlaxoSmithKline
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 48
Sex ALL
Min Age 18 Years
Max Age 55 Years
Start Date 2024-11-18
Completion 2026-04-23
Interventions
GSK4528287Placebo

Brief Summary

"GSK4528287 is a drug being developed to treat like inflammatory bowel diseases like Crohns disease and ulcerative colitis. This study is the first time that GSK4528287 will be given to humans. The study will test single doses of GSK4528287 to check for side effects, measure blood levels, and understand how it works in the body. The study will start with a small dose, and the dose will be increased for each new group of participants."

Eligibility Criteria

Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring * White blood cell greater than or equal to (\>=) lower limit of normal (LLN), including both lymphocyte counts \>= LLN and neutrophil counts \>= LLN, at both screening and pre-dose (Day-1) Note: in cases where the test is abnormal, the participant may have the test repeated once and if their second test is normal, they will be eligible. In the event a second test is also abnormal, the participant is not eligible * Electrocardiogram (ECG) with no clinically significant abnormality at the discretion of the investigator/designee * Participants with a confirmed positive vaccination status for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines as per local/site guidance * SARS-CoV-2 screening test negative as per local guidance * If dosing is during influenza season (October to April per l

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