GSK2618960, an anti-IL7-R monoclonal antibody, in healthy volunteers
Research type
Research Study
Full title
A Randomised, Double-Blind (Sponsor Unblind), Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Single Ascending Doses of a Fully Humanized Anti-IL-7 Receptor a Monoclonal Antibody (GSK2618960) in Healthy Volunteers.
IRAS ID
155134
Contact name
Disala Fernando
Contact email
Sponsor organisation
GSK Research & Development, Projects Clinical Platforms & Sciences
Eudract number
2014-001275-30
Research summary
GlaxoSmithKline (GSK) is developing the monoclonal antibody GSK2618960 as a potential medicine for auto-immune diseases. In those diseases, the body’s own immune system attacks healthy organs and tissues by mistake. Some of the cells in the immune system (called lymphocytes) attack when a protein, called IL7, binds to a receptor for IL7 (IL7R) on the surface of those cells. The antibody GSK2618960 blocks IL7R, which might reduce the damage caused by lymphocytes in auto-immune diseases.
This will be the second study in humans to test GSK2618960. In the first study, 12 healthy volunteers had a single dose of GSK2618960 by intravenous administration (a slow injection into a vein). 4 dose levels were tested. The results of the first study showed that it is safe to test higher doses of GSK2618960. In this study, 2 higher dose levels will be tested. We will monitor for side effects, and measure blood levels and effects of GSK2618960.
There will be two groups of 9 healthy volunteers, each receiving a single dose of either GSK2618960 or placebo (dummy medicine). In each group, 3 volunteers will receive placebo and 6 will receive GSK2618960. Volunteers will be monitored for up to 24 weeks after the dose. The drug will have gone from the body during that time.
This study will be double-blind, where the study doctors, study team and volunteers are unaware of whether GSK2618960 or placebo is being given.
Taking part in the study will not have direct benefit to volunteers. All volunteers will be admitted to a specialist clinical research unit with adequate safety and compliance facilities for conducting this research.
The data from this study will help to design future studies with GSK2618960 in patients.
The study is sponsored by GlaxoSmithKline.REC name
London - Brent Research Ethics Committee
REC reference
14/LO/1670
Date of REC Opinion
9 Oct 2014
REC opinion
Favourable Opinion