A FTIH study of GSK4528287 in Healthy Participants
Research type
Research Study
Full title
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
IRAS ID
1010271
Contact name
Suzan Yuen
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Clinicaltrials.gov Identifier
Research summary
GSK is developing a molecule called a bispecific antibody to treat inflammatory bowel diseases (IBD) like Crohn’s disease and ulcerative colitis caused by the immune system attacking the gut. The GSK4528287 molecule (the IMP) is designed to block small proteins called cytokines IL-23 and IL-18. These both regulate inflammation in the gut and are mainly produced by a wide range of cell types including lymphocytes (types of white blood cell) and inflamed mucosal cells (lining the gut).
There is strong evidence that IL-23 has an important role to regulate and trigger inflammation in many diseases, including psoriasis and IBD. An antibody blocking IL-23 is currently approved for treatment of moderate-to-severe IBD and psoriasis. Real world data and phase III trials show an excellent efficacy and safety profile of IL-23 therapy in patients with IBD.
IL-18 also plays role in gut inflammation and can make the disease worse by causing more harm to protective lining of the gut. There is increasing evidence that IL-18 may be a key factor in IBD. A combined therapy blocking both IL-23 and IL-18 is expected to have significant impact on IBD remission rates.
This is a first time in human, double-blinded, placebo-controlled study in healthy volunteers (HV). The main aim of this study is to assess safety and tolerability of the IMP intended to treat patients with IBD, and how it is handled in the body (pharmacokinetics). The IMP will be given as an intravenous (IV) or subcutaneous (SC) dose. HVs who have an IV dose will stay in the unit for 4 days; those having a SC dose will stay for 9 days. During the stay, HVs will be closely monitored for adverse reactions and have study assessments including safety and pharmacokinetic blood tests, and other safety procedures. All HVs will need to attend up to 15 outpatient visits over up to 48 weeks.REC name
South Central - Berkshire Research Ethics Committee
REC reference
24/SC/0294
Date of REC Opinion
29 Oct 2024
REC opinion
Further Information Favourable Opinion