GSK-4528287 | Advanced Drug Monograph

GSK-4528287 Medication Report

Name: GSK-4528287 English Name: GSK-4528287 Drug Type: Unknown Target: Unknown Action: Unknown Mechanism: Unknown Therapeutic Areas: Immune System Diseases, Digestive System Disorders Active Indication: Ulcerative Colitis Inactive Indication: None listed Originator Organization: GSK Plc Active Organization: GSK Plc Inactive Organization: None listed License Organization: None listed Drug Highest Phase: Phase 1 First Approval Date: Not yet approved Regulation: Unknown

R&D Status

Highest Phase: Phase 1 for Ulcerative Colitis in the United Kingdom.
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 is currently recruiting (NCT06681181).
Estimated Primary Completion Date (NCT06681181): October 23, 2025
Estimated Study Completion Date (NCT06681181): September 9, 2026

Clinical Trials

NCT06681181: A First-time in Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK4528287 in Healthy Participants.
- Phase: 1
- Status: Recruiting
- Enrollment: 48 participants (estimated)
- Age: 18 to 55 years
- Location: United Kingdom
- Sponsor: GlaxoSmithKline (GSK)
- Primary Outcome: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) as assessed by the Investigator.
- Secondary Outcomes: Pharmacokinetic parameters (Cmax, AUCinf, tmax, half-life), assessment of target engagement biomarkers in blood.

Product Description

GSK4528287 is being developed for inflammatory bowel diseases like ulcerative colitis.
The current Phase 1 study (NCT06681181) is the first time this drug will be given to humans.
The study will test single ascending doses to assess safety, tolerability, pharmacokinetics, and target engagement.

Synonyms

GSK 4528287
GSK4528287

Additional Information

GSK-4528287 is an antibody.
No FDA designation is currently listed.