Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus

NCT07096193 · tracked via the Priya Life Science Turkey tracker

Sponsor

Gilead Sciences

Phase

Phase 1/2

Started

2025-07-31

Last updated

2026-08-27

Condition(s) studied

Chronic Hepatitis Delta

Investigational drug(s) / intervention(s)

GS-4321GS-4321 PlaceboGS-4321

GS-4321: Administered subcutaneous (SC) or intravenously IV

GS-4321 Placebo: Administered SC

GS-4321: Administered SC

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

69 Years

Healthy volunteers

Accepted

Key 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. Key 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.

Primary outcome measure(s)

Phase 1 and 2: Percentage of Participants With Treatment-emergent Adverse Events — Phase 1: First dose up to 44 weeks; Phase 2: First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up
Phase 1 and 2: Percentage of Participants With Treatment-emergent Serious Adverse Events — Phase 1: First dose up to 44 weeks; Phase 2: First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up
Phase 1 and 2: Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities — Phase 1: First dose up to 44 weeks; Phase 2: First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up
Phase 1: Serum Pharmacokinetic (PK) parameter; AUC of GS-4321 — First dose up to 24 Weeks
AUC is defined as the area under the concentration versus time curve
Phase 1: Serum PK Parameter: Cmax — First dose up to 24 Weeks
Cmax is defined as the maximum observed concentration of drug.
Phase 1: Serum PK Parameter: Tmax — First dose up to 24 Weeks
Tmax is defined as the time (observed time point) of Cmax.
Phase 1: Serum PK Parameter: t1/2 — First dose up to 24 Weeks
Phase 2: Proportion of Participants with Combined Response — Up to 96 Weeks
Combined Response is defined as undetectable hepatitis delta virus (HDV) RNA or ≥ 2 log10 decrease in HDV RNA from baseline and normal alanine aminotransferase (ALT) normalization (ALT \< upper limit of normal (ULN) at week 24).

Trial sites (28)

Facility	City	Region	Status
Investigative Site	Anaheim	California	Recruiting
University of California, San Diego - Altman Clinical and Translational Research Institute	La Jolla	California	Recruiting
University of Louisville, Clinical Trials Unit	Louisville	Kentucky	Recruiting
University of Maryland, Institute of Human Virology, Clinical Research Unit	Baltimore	Maryland	Recruiting
The New York-Presbyterian Hospital	New York	New York	Recruiting
University Multi-profile Hospital for Active Treatment "SofiaMed" 00D	Sofia	Bulgaria	Recruiting
Medizinische Hochschule Hannover, Address: Klinik für Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie	Hanover	Germany	Recruiting
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, SC Gastroenterologia ed Epatologia	Milan	Italy	Recruiting
IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba"	Chinsinau	Moldova	Recruiting
PMSI Clinical Republican Hospital "Timofei Mosneaga"	Chisinau	Moldova	Recruiting
Institutul National De Boli Infectioase Prof. Dr. Matei Bals	Bucharest	Romania	Recruiting
Fundatia Dr. Victor Babes	Bucharest	Romania	Recruiting
Infectious Diseases Institutul National De Boli Infectioase Prof. Matei Bals	Bucharest	Romania	Recruiting
Gastromedica S.R.L.	Iași	Romania	Recruiting
Korea University Ansan Hospital	Ansan-si	South Korea	Recruiting
The Catholic University of Korea Bucheon St. Mary's Hospital	Bucheon-si	South Korea	Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul	South Korea	Recruiting
Samsung Medical Center	Seoul	South Korea	Recruiting
Ditmanson Medical Foundation Chia-Yi Christian Hospital	Chiayi City	Taiwan	Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung City	Taiwan	Recruiting
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital	Kaohsiung City	Taiwan	Recruiting
National Taiwan University Hospital	Taipei	Taiwan	Recruiting
Hacettepe University Faculty of Medicine Hospital Hacettepe Neighborhood	Ankara	Turkey (Türkiye)	Recruiting
Ankara Bilkent City Hospital Oncology Hospital Universiteler Neighborhood	Ankara	Turkey (Türkiye)	Recruiting
Ankara Bilkent City Hospital Universiteler Neighborhood, 1604th Street No: 9,	Ankara	Turkey (Türkiye)	Recruiting
Dicle University Faculty of Medicine	Diyarbakrir	Turkey (Türkiye)	Recruiting
Istabul University-Cerrahpasa Faculty of Medicine Hospital	Istanbul	Turkey (Türkiye)	Recruiting
Koc University Medical Faculty Hospital	Istanbul	Turkey (Türkiye)	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07096193 on ClinicalTrials.gov ↗ ← All trials in Turkey