First time in human study of GSK3358699 in healthy males
Research type
Research Study
Full title
A randomised, double-blind (sponsor open), placebo-controlled, three part study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single (in both fed and fasted states) or repeat doses of GSK3358699 in healthy male participants.
IRAS ID
238369
Contact name
Disala Fernando
Contact email
Sponsor organisation
GSK
Eudract number
2017-003997-15
Duration of Study in the UK
1 years, 2 months, 19 days
Research summary
GlaxoSmithKline (GSK) is developing a new medicine, GSK3358699, which may help people suffering from diseases of their immune system. An example of one such disease is Rheumatoid Arthritis (RA). This is a debilitating joint disease, which affects over 400,000 people in the UK and can have a devastating impact on a person’s overall quality of life, costing the UK economy up to an estimated £4.8 billion annually.
In laboratory studies, GSK3358699 blocks certain proteins that play a very important role in immune-diseases such as RA. This clinical study will seek to understand how well healthy humans tolerate GSK3358699 and will measure blood levels of GSK3358699 in humans. It will also help us understand the effect of GSK3358699 on cells and proteins involved in immune-diseases like RA.
GSK will conduct this study in at least 80 healthy male participants aged 18 to 45 years. The study has three parts:
• Part A (approximately 23 weeks): 18 participants, in two equal groups will receive one oral dose of GSK3358699 or a dummy (placebo) treatment up to 4 times, with slight planned increases in the dose. This part of the study will involve up to four inpatient stays to the unit. During the fourth visit, participants will also receive injections, which will activate the immune system.
• Part B (approximately 9 weeks): 6 participants will receive one oral dose of GSK3358699 either with or without food across two inpatient stays to the clinical unit.
• Part C (approximately 12 weeks): Up to four groups of 14 participants will receive either GSK3358699 or placebo orally for 14 days and may receive injections like in Part A.The study is sponsored by GSK, and will be conducted in a Medicines and Health Care Products Regulatory Agency (MHRA) accredited clinical research unit in the UK.
REC name
Wales REC 2
REC reference
18/WA/0004
Date of REC Opinion
24 Jan 2018
REC opinion
Favourable Opinion