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NCT07096193PHASE1, PHASE2RecruitingAccepts Healthy Volunteers

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

Gilead Sciences

Start Date

7/31/2025

Completion Date

1/1/2030

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 Criteria

Age Range: 18 years to 69 years

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.

Interventions

DRUG

GS-4321

DRUG

GS-4321 Placebo

DRUG

GS-4321

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Conditions

Chronic Hepatitis Delta

Locations

Investigative Site

Anaheim, California 92801

United States

University of Louisville, Clinical Trials Unit

Louisville, Kentucky 40202

United States

University of Maryland, Institute of Human Virology, Clinical Research Unit

Baltimore, Maryland 21201

United States

The New York-Presbyterian Hospital

New York, New York 10021

United States

University Multi-profile Hospital for Active Treatment "SofiaMed" 00D

Sofia, 1797

Bulgaria

Medizinische Hochschule Hannover

Hanover, 30625

Germany

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, SC Gastroenterologia ed Epatologia

Milan, 882

Italy

IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba"

Chinsinau, 2004

Moldova

IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba"

Chisinau, 2004

Moldova

PMSI Clinical Republican Hospital "Timofei Mosneaga"

Chisinau, MD-2025

Moldova

Institutul National De Boli Infectioase Prof. Dr. Matei Bals

Bucharest, 021105

Romania

Fundatia Dr. Victor Babes

Bucharest, 030303

Romania

Infectious Diseases Institutul National De Boli Infectioase Prof. Matei Bals

Bucharest, 21105

Romania

Gastromedica S.R.L.

Iași, 700506

Romania

Korea University Ansan Hospital

Ansan-si, 425-707

South Korea

The Catholic University of Korea Bucheon St. Mary's Hospital

Bucheon-si, 14647

South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 06591

South Korea

Samsung Medical Center

Seoul, 135-710

South Korea

Ditmanson Medical Foundation Chia-Yi Christian Hospital

Chiayi City,

Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807

Taiwan

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301

Taiwan

National Taiwan University Hospital

Taipei, 100

Taiwan