First in human study of anti-OSM monoclonal antibody (GSK2330811)
Research type
Research Study
Full title
A Phase I, Randomised, Double-blind (sponsor open), Placebo-Controlled Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330811 in Healthy Subjects
IRAS ID
171495
Contact name
Disala Fernando
Contact email
Sponsor organisation
GSK Research & Development, Projects Clinical Platforms & Sciences
Eudract number
2014-004967-19
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
GlaxoSmithKline (GSK) is developing a new medicine (GSK2330811), for the treatment of inflammatory and fibrotic diseases, such as Systemic Sclerosis. GSK2330811 is a humanised monoclonal antibody (a type of protein engineered to resemble a human protein) which blocks the activity of a substance in the body called Oncostatin (OSM), by binding to it and impacting the key components of these diseases.
This is the first time GSK2330811 will be given to human volunteers We will look at the safety and tolerability of different doses of GSK2330811, how long the body takes to get rid of it and how the medicine works in the body. We will also use a well established experimental technique, called the suction blister model, to measure GSK2330811 and OSM levels in blister fluid.
Approximately 40 healthy volunteers will participate in the study comparing GSK2330811 and a placebo (a dummy drug made with salty water called saline). There will be 5 groups and each group will have 8 volunteers. Each volunteer will receive a subcutaneous (under the skin) dose of the study medication via injection/s in the abdomen. The number of injections will increase from 1 up to a maximum of 4 as the dose increases. In each group, 2 volunteers will receive the placebo and 6 will receive GSK2330811. 24 volunteers in the last 3 groups will have a suction blister formed on the skin of their forearms and the blister fluid will be collected.
Anticipated study duration and number of visits: a total of up to 19 weeks (approximately 5 months). In total 11 outpatient visits, and 8 days inpatient stay being resident in the Clinical Unit Cambridge. The study is sponsored by GlaxoSmithKline and will be conducted in a specialist clinical research unit in the UK, with adequate safety and compliance facilities.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
15/EE/0090
Date of REC Opinion
25 Mar 2015
REC opinion
Favourable Opinion