NCT06681181

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

A Phase 1, Randomized, Double-Blind, Placebo Controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK4528287 in Healthy Participants

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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."

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	GSK4528287	GSK4528287 will be administered.
DRUG	Placebo	Placebo will be administered.

Timeline

• Start date: 2024-11-18
• Primary completion: 2026-04-23
• Completion: 2027-02-25
• First posted: 2024-11-08
• Last updated: 2026-04-06

Locations

1 site across 1 country: United Kingdom