GSK-4528287

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.