Actively Recruiting
Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus
Led by Gilead Sciences · Updated on 2026-04-29
107
Participants Needed
15
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goals of this clinical study are to first learn more about safety and dosing of the study drug GS-4321 in healthy participants. The study will then learn about the safety and effectiveness of GS-4321 in participants with chronic hepatitis delta (CHD). The primary objective of Phase 1 of this study is to evaluate the safety, tolerability and Pharmacokinetics (PK) of the escalating single doses of GS-4321 administered in healthy participants. The primary objective of Phase 2 of this study is to evaluate the efficacy and safety of the multiple escalating doses of GS-4321 in participants with CHD.
CONDITIONS
Official Title
Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified contraception methods.
- Body mass index (BMI) of 30.0 kg/m2 or less at screening and admission.
- Chronic hepatitis delta (CHD) for at least 6 months prior to screening, documented by medical history.
- Receiving commercially available entecavir, TAF, or TDF for hepatitis B virus infection at or before enrollment; fixed-dose combinations for HIV treatment allowed.
- Non-cirrhotic or compensated cirrhosis liver status.
- Hepatitis delta virus RNA level greater than 100 IU/mL at screening.
- Alanine aminotransferase (ALT) level higher than 1 times but less than 10 times the upper limit of normal at screening.
You will not qualify if you...
- Positive serum or urine pregnancy test.
- Plans to breastfeed during the study period.
- Current or past clinically decompensated liver disease, including coagulopathy, hepatic encephalopathy, or bleeding from esophageal varices caused by HDV or HBV.
- Child-Turcotte-Pugh (CTP) score of 7 or higher or classified as CTP-B or CTP-C.
AI-Screening
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Trial Site Locations
Total: 15 locations
1
Investigative Site
Anaheim, California, United States, 92801
Actively Recruiting
2
University of Maryland, Institute of Human Virology, Clinical Research Unit
Baltimore, Maryland, United States, 21201
Actively Recruiting
3
The New York-Presbyterian Hospital
New York, New York, United States, 10021
Actively Recruiting
4
IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba"
Chinsinau, Moldova, 2004
Actively Recruiting
5
PMSI Clinical Republican Hospital "Timofei Mosneaga"
Chisinau, Moldova, MD-2025
Actively Recruiting
6
Institutul National De Boli Infectioase Prof. Dr. Matei Bals
Bucharest, Romania, 021105
Actively Recruiting
7
Fundatia Dr. Victor Babes
Bucharest, Romania, 030303
Actively Recruiting
8
Infectious Diseases Institutul National De Boli Infectioase Prof. Matei Bals
Bucharest, Romania, 21105
Actively Recruiting
9
Gastromedica S.R.L.
Iași, Romania, 700506
Actively Recruiting
10
Korea University Ansan Hospital
Ansan-si, South Korea, 425-707
Actively Recruiting
11
The Catholic University of Korea Bucheon St. Mary's Hospital
Bucheon-si, South Korea, 14647
Actively Recruiting
12
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
13
Samsung Medical Center
Seoul, South Korea, 135-710
Actively Recruiting
14
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Actively Recruiting
15
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 83301
Actively Recruiting
Research Team
G
Gilead Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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