GS-US-439-4660: Phase1 study of GS-4224 in participants with CHB virus
Research type
Research Study
Full title
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GS-4224 in Healthy Volunteers and Subjects with the Chronic Hepatitis B (CHB) Virus
IRAS ID
261608
Contact name
Kaushik (Kosh) Agarwal
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2019-000811-10
Clinicaltrials.gov Identifier
ACTRN12618001957280p, ANZCTR Trial ID
Duration of Study in the UK
1 years, 1 months, 30 days
Research summary
This study is investigating the medication known as GS-4224 in participants with Chronic Hepatitis B (CHB) virus. This is the first time this medication is being tested in CHB patients. This study’s main aim is to see how safe and tolerable this medication is in patient’s with CHB.
This study will involve approximately 60 participants (male and female aged 18-65 years of age) across up to 15 sites globally. In the UK, this study will be conducted at one NHS Hospital. In this study participants will be assigned to either GS-4224 or placebo (a tablet with no active medicine in). Participants eligible to take part in this study may be assigned to up to 1 of 6 groups, known as cohorts.
Participants may be in the study for up to 59 days (not including screening). During this time participants will have to visit the site up to 14 times. The study is made up of the following parts:
# Screening: Participant’s will be assessed by the study doctor to see if they are eligible to take part.
# Study medication: Participants will take GS-4224 or placebo for 28 days, this includes 7 study visits.
# Post Treatment visits: Participants will be asked to attend the site 6 times after their treatment, over a total of 28 days.During participation in the study, participants will undergo some of the following procedures and tests: physical exams, assessment of vital signs, blood sample tests, urine tests, ECG test, Chest X-Ray and stool sample tests etc.
Participants will also have the option to take part in a genomic sub-study and a leukapheresis (separating white blood cells from the blood) sub-study. Participants can take part in the main study even if they do not wish to take part in these optional sub-studies.REC name
London - Central Research Ethics Committee
REC reference
19/LO/0532
Date of REC Opinion
11 Oct 2019
REC opinion
Further Information Favourable Opinion