First Time in Human Study of GSK3335065 in Healthy Adults
Research type
Research Study
Full title
Randomized, Double-blind, Placebo Controlled Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses (Intravenous bolus) and constant intravenous infusion over 7 Days of GSK3335065 in Healthy Adult Subjects
IRAS ID
224819
Contact name
Disala Fernando
Contact email
Eudract number
2016-001303-22
Duration of Study in the UK
0 years, 9 months, 27 days
Research summary
Glaxosmithkline (GSK) is developing a new medicine (GSK3335065) for the treatment of acute pancreatitis (AP), a sudden and severe inflammatory disease of the pancreas. Patients with AP have unusually high levels of a protein called 3-HK (3-hydroxykynuenine). GSK3335065 will work to reduce levels of 3-HK and other related proteins by blocking their production.
This is the first time that GSK3335065 will be given to humans. The main purpose of the study is to assess the safety, tolerability and blood levels of GSK3335065. The study will also help determine a suitable dose of GSK3335065 and provide clarity on how GSK3335065 acts to control AP. GSK3335065 will be given intravenously (IV; directly into the vein).
The study will be conducted in healthy volunteers in 3 parts:
•In Part A, 16 male volunteers will receive single doses of either GSK3335065 or placebo as a single IV injection at four different visits.
•In Part B, 32 male volunteers will receive repeated doses of either GSK3335065 or placebo as a single IV injection on Day 1, followed by a continuous IV infusion for seven days.
•In Part C, 16 women (non-child bearing potential) will be divided into two groups and will receive either GSK3335065 or placebo as one single dose or as repeated doses (similar to Part B).
The total duration of Part A and Part B will be approximately 19 and 13 weeks respectively, and that of the two groups in Part C will be approximately 7 and 13 weeks respectively.
Taking part in the study will not have a direct benefit to volunteers. 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 United Kingdom, with adequate safety and compliance facilities.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0337
Date of REC Opinion
1 Aug 2017
REC opinion
Further Information Favourable Opinion