202007 - FTIH of GSK3389404 in HV
Research type
Research Study
Full title
A Double-Blind, Placebo-Controlled, Dose-Escalation, First Time in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of GSK3389404 in Healthy Subjects
IRAS ID
188458
Contact name
Melanie Paff
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited, Liver Unit
Eudract number
2015-003781-84
Duration of Study in the UK
0 years, 10 months, 3 days
Research summary
GSK3389404 is being developed by GlaxoSmithKline Research & Development Limited, (the Sponsor, a pharmaceutical company based in Middlesex, UK) and this study is being carried out on behalf of the Sponsor by Quintiles.
GSK3389404 is an investigational drug that may be useful in the treatment of Chronic Hepatitis B (CHB) infection. This is a serious health problem world wide, and current treatment is unsatisfactory.
This is a First Time in Human, Phase 1, 2-part study.
The purpose of this study is to examine the safety, tolerability and the way the body handles (absorbs, distributes, breaks down and excretes) following various single ascending dose (Part 1) and multiple ascending dose (Part 2) injections of GSK3389404 in healthy volunteers who are not carriers of hepatitis B.
The total duration of Part 1 is expected to last no longer than 13 weeks, and Part 2 no longer than 21 weeks.
REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/1830
Date of REC Opinion
8 Dec 2015
REC opinion
Further Information Favourable Opinion