OVERVIEW
Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta
PROTOCOL SUMMARY
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.
View moreParticipation requirements
Age
18 years - 69 years
Sex
All
Healthy Volunteers
true
Age
18 years - 69 years
Sex
All
Healthy Volunteers
true
Study details
Medical Condition
Chronic Hepatitis Delta
Gender
N/A
Date
July 2025 - January 2030
Study Type
Interventional
Study Phase
Phase 1, Phase 2
Product
GS-4321, GS-4321 Placebo, GS-4321
Eligibility information
Inclusion criteria
- Part A:
- Participants assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
- Have a body mass index (BMI) of ≤ 30.0 kg/m2 at screening and at admission.
- Part B:
- Participants assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
- Chronic hepatitis delta (CHD) for ≥ 6 months prior to screening, documented by prior medical history.
- Must be receiving a commercially available entecavir, TAF, or TDF for the treatment of hepatitis B virus (HBV) infection at or prior to enrollment. Coformulation as part of a fixed-dose combination for the treatment of HIV is permitted.
- Non-cirrhotic or compensated cirrhosis.
- Hepatitis delta virus ribonucleic acid (HDV RNA ) > 500 IU/mL at screening.
- Alanine aminotransferase (ALT) level > 1 × Upper limit of normal (ULN), but < 10 × ULN at screening.
Exclusion criteria
- Part A:
- Positive serum or urine pregnancy test.
- Participants with plans to breastfeed during the study period.
- Part B:
- Positive serum or urine pregnancy test.
- Participants with plans to breastfeed during the study period.
- Current or previous clinically decompensated liver disease, including coagulopathy, hepatic encephalopathy, and esophageal varices hemorrhage due to HDV or HBV.
- Child-Turcotte-Pugh (CTP)-B or -C or a CTP score of ≥ 7.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (28)
University of California, San Diego - Altman Clinical and Translational Research Institute
La Jolla, California, United States, 92093
University of Louisville, Clinical Trials Unit
Louisville, Kentucky, United States, 40202
University of Maryland, Institute of Human Virology, Clinical Research Unit
Baltimore, Maryland, United States, 21201
The New York-Presbyterian Hospital
New York, New York, United States, 10021
University Multi-profile Hospital for Active Treatment "SofiaMed" 00D
Sofia, Bulgaria, 1797
Medizinische Hochschule Hannover, Address: Klinik für Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie
Hanover, Germany, 30625
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, SC Gastroenterologia ed Epatologia
Milan, Italy, 882
IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba"
Chinsinau, Moldova, 2004
PMSI Clinical Republican Hospital "Timofei Mosneaga"
Chisinau, Moldova, MD-2025
Institutul National De Boli Infectioase Prof. Dr. Matei Bals
Bucharest, Romania, 021105
Infectious Diseases Institutul National De Boli Infectioase Prof. Matei Bals
Bucharest, Romania, 21105
The Catholic University of Korea Bucheon St. Mary's Hospital
Bucheon-si, South Korea, 14647
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City, Taiwan,
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 83301
Hacettepe University Faculty of Medicine Hospital Hacettepe Neighborhood
Ankara, Turkey (Türkiye), 06430
Ankara Bilkent City Hospital Oncology Hospital Universiteler Neighborhood
Ankara, Turkey (Türkiye), 06800
Ankara Bilkent City Hospital Universiteler Neighborhood, 1604th Street No: 9,
Ankara, Turkey (Türkiye), 6800
Dicle University Faculty of Medicine
Diyarbakrir, Turkey (Türkiye), 21280
Istabul University-Cerrahpasa Faculty of Medicine Hospital
Istanbul, Turkey (Türkiye), 34000
Koc University Medical Faculty Hospital
Istanbul, Turkey (Türkiye), 34010
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