A two-part Ph 1 study to investigate GSK3862995B in healthy participants and participants with COPD
Research type
Research Study
Full title
A two-part Phase 1 randomized, double-blind, placebo-controlled study to investigate safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of GSK3862995B following single ascending doses in healthy participants and repeat doses in participants with Chronic Obstructive Pulmonary Disease
IRAS ID
1008623
Contact name
Suki Parry
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd.
Eudract number
2023-506880-32
Research summary
Chronic obstructive pulmonary disease (COPD) is a group of common lung diseases which are lifelong, progressive and can be life-threatening. In COPD, the airways become permanently narrowed due to inflammation, making it difficult to move air through the lungs. COPD patients can get short of breath easily, have a cough or wheeze, produce phlegm and get frequent chest infections. GSK is developing a drug (GSK3862995B) for the treatment of COPD. Current COPD therapies help reduce symptoms but do not work to slow the progression of the disease. It is expected that GSK3862995B will work in a different way to current treatments. GSK3862995B is a monoclonal antibody (a type of protein) that works by recognizing and attaching to a specific target in the body. GSK3862995B works by blocking the activity of interleukin 33 (IL-33), a protein occurring naturally in the body that produces inflammation which can lead to tissue damage. Research has shown that blocking IL-33 may reduce inflammation in the lungs which may improve breathing and prevent COPD flare-ups. This is the first time that GSK3862995B will be given to humans. It has only been tested on animals and in the laboratory. The study drug works similarly to two drugs that have been tested in humans by other pharmaceutical companies.
The study will include 138 participants in two parts. Part A will have 48 healthy men and women of non-childbearing potential (aged 18-65 years) and will last for 40 weeks. Participants will receive one ascending dose of GSK3862995B or placebo by either an intravenous infusion or an injection. Part B will have 90 men and women of non-childbearing potential (aged 40–75 years) with COPD. They will receive two repeat doses of GSK3862995B or placebo by injection with the study lasting 52 weeks.
Participants in Part A will not benefit directly, patients in Part B may have short term medical benefit. Both groups may help GSK to develop a new drug for an unmet need in COPD.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0356
Date of REC Opinion
7 Nov 2023
REC opinion
Further Information Favourable Opinion