Safety, blood levels and effects of GSK2831781
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled Phase I study of the safety and tolerability, pharmacokinetics, and pharmacodynamics of a single intravenous dose of GSK2831781 in healthy Japanese and Caucasian participants, and a single subcutaneous dose of GSK2831781 in healthy Caucasian participants (18-029).
IRAS ID
262446
Contact name
Frans van den Berg
Contact email
Sponsor organisation
GSK
Eudract number
2019-000832-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study medicine (GSK2831781) is an experimental new medicine for treating inflammatory diseases. In patients with inflammatory diseases, the immune system can’t tell the difference between healthy body tissue and harmful substances, leading to inflammation (swelling). There are higher levels of a particular immune cell (LAG3+ T cells) in areas that are inflamed. The study medicine contains a large protein called a ‘monoclonal antibody’, which is made specifically for use in humans. It’s designed to attach to LAG3+ T cells, leading to fewer of these cells and reduced inflammation. \n\nGSK2831781 has already been tested when given by slow injection into a vein, which has to be done by a doctor or nurse. So we’d now like to test GSK2831781 when it’s injected under the skin, so patients should be able to dose themselves. GSK2831781 could be a useful treatment for patients in many countries. So, we also need to find out whether the blood levels, safety and effects of the study medicine vary among particular ethnic groups. \n\nThe study will have 2 parts. We’ll give a single dose of GSK2831781 by slow injection into a vein to up to 32 healthy Caucasian and Japanese men (Part A) or by an injection under the skin to up to 30 Caucasian men (Part B). We’ll aim to find out the blood levels of GSK2831781, any side effects and whether the body reacts to GSK2831781; in particular, whether the body makes antibodies against it. \n\nWe’ll screen participants 4 weeks before they start the study. Participants will take about 16 weeks to finish the study. They’ll stay on the ward for 2 nights and make up to 11–14 outpatient visits, depending on the study part. \n\nA pharmaceutical company (GSK) is funding the study.\n\nThe study will take place at 1 centre in London.
REC name
HSC REC B
REC reference
19/NI/0077
Date of REC Opinion
16 May 2019
REC opinion
Further Information Favourable Opinion