207804 A two-part phase I study of GSK3858279
Research type
Research Study
Full title
A two-part phase I randomized double blind (sponsor open) placebo controlled study to evaluate safety, tolerability, pharmacokinetics, target engagement and potential for efficacy of single intravenous and subcutaneous doses of GSK3858279 in healthy volunteers and participants with osteoarthritis of the knee.
IRAS ID
243846
Contact name
Fernando Disala
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2017-004809-41
Duration of Study in the UK
1 years, 4 months, 14 days
Research summary
This is a two-part phase I study (this means that this is the first time the study drug will be given to humans) in healthy volunteers and participants with osteoarthritis of the knee.
The study has 2 main parts (Part A and Part B) the UK is only participating in part A.
Purpose of Part "A" - for male and female (of non-reproductive potential) healthy volunteers aged 18-65 years:
• To find the highest dose of the study drug (GSK3858279) that is as safe as possible and does not cause unacceptable side effects. This will be done by first testing low doses of the study drug in some participants, followed by higher doses of study drug in other participants.
• Test how the study drug works and look at what happens to the study drug in the body
The study drug will be given by one injection - either into a vein, or directly into the thin layer of fat under the skin. This will be studied in healthy participants.
About 48 participants in 1 study center (Clinical Unit Cambridge) will take part in this study. The 48 volunteers will be divided into 6 different dosing groups (from lowest dose to highest dose). Each group will have 8 participants, with 6 participants receiving the study drug and 2 participants receiving placebo (a dummy drug that looks like the study drug but does not contain any active ingredient).REC name
London - Brent Research Ethics Committee
REC reference
18/LO/0498
Date of REC Opinion
14 May 2018
REC opinion
Further Information Favourable Opinion