Safety, blood levels and effects of GSK2330811 in Japanese volunteers
Research type
Research Study
Full title
A phase 1, randomised, double-blind, placebo-controlled study of the safety, tolerability, pharmacokinetics and pharmacodynamics of single subcutaneous doses of GSK2330811 in healthy Japanese participants. HMR code: 19-007
IRAS ID
271565
Contact name
Rabia Anselm
Contact email
Sponsor organisation
GSK
Eudract number
2019-003042-33
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study medicine (GSK2330811) is an experimental new medicine for treating certain diseases, such as Crohn’s disease and systemic sclerosis. GSK2330811 consists of a large protein called a ‘monoclonal antibody’, which is made specifically for use in humans. It works by blocking the activity of a protein in the body called Oncostatin M (OSM), which is expected to have a beneficial effect on some of the signs and symptoms of systemic sclerosis and Crohn’s disease such as fibrosis (build-up of fibrous tissue) and inflammation (redness, swelling and pain). We hope that GSK2330811 may improve the disease and help reduce symptoms for patients with Crohn’s disease and systemic sclerosis.
If studies with GSK2330811 are successful, it may be a useful treatment in many countries, including Japan. It’s currently being tested in a study in patients with systemic sclerosis and has also been tested in 30 healthy people, most of whom were Caucasian. We need to see whether the effects vary between ethnic groups, so we’re doing this study in healthy Japanese people.
We’ll give up to 10 healthy Japanese men, aged 18 to 65, a single dose of GSK2330811 by injection under the skin. We aim to find out the blood levels of GSK2330811 and any side effects. We’ll also investigate whether the body reacts to the GSK2330811; in particular, whether the body makes antibodies against it, and the effects on the blood (haemoglobin, platelets, erythropoietin and thrombopoietin) and immune cells (OSM).
We’ll screen participants up to 4 weeks before they start the study. Participants will take about 18 weeks to finish the study. They’ll stay on the ward for 2 nights and make up to 11 outpatient visits.
A pharmaceutical company (GSK) is funding the study.
The study will take place at 1 centre in London.
Word count: 296/300
REC name
London - Harrow Research Ethics Committee
REC reference
19/LO/1426
Date of REC Opinion
29 Nov 2019
REC opinion
Further Information Favourable Opinion