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STATUS Recruiting

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

LAST UPDATED

June 11 2026

Clinicaltrials.gov ID

NCT07096193

CTSID

2025-522729-36

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.

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Participation Requirements

Calendar

Age

18 Years - 69 Years

Condition

Sex

ALL

Healthy Icon

Healthy Volunteers

true

Study Details

Medical Condition

Chronic Hepatitis Delta

Gender

N/A

Date

July 2025 - January 2030

Study Type

INTERVENTIONAL

Study Phase

PHASE1, PHASE2

Product

GS-4321, GS-4321 Placebo, GS-4321

Eligibility Information

Inclusion

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.
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Exclusion

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.
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Locations

Locations (19)
Recruiting

Investigative Site

Anaheim, California, United States, 92801

Recruiting

University of Louisville, Clinical Trials Unit

Louisville, Kentucky, United States, 40202

Recruiting

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

Baltimore, Maryland, United States, 21201

Recruiting

The New York-Presbyterian Hospital

New York, New York, United States, 10021

Recruiting

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

Milan, Italy, 882

Recruiting

IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba"

Chinsinau, Moldova, 2004

Recruiting

IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba"

Chisinau, Moldova, 2004

Recruiting

PMSI Clinical Republican Hospital "Timofei Mosneaga"

Chisinau, Moldova, MD-2025

Recruiting

Institutul National De Boli Infectioase Prof. Dr. Matei Bals

Bucharest, Romania, 021105

Recruiting

Fundatia Dr. Victor Babes

Bucharest, Romania, 030303

Recruiting

Infectious Diseases Institutul National De Boli Infectioase Prof. Matei Bals

Bucharest, Romania, 21105

Recruiting

Gastromedica S.R.L.

Iași, Romania, 700506

Recruiting

Korea University Ansan Hospital

Ansan-si, South Korea, 425-707

Recruiting

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

Bucheon-si, South Korea, 14647

Recruiting

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

Seoul, South Korea, 06591

Recruiting

Samsung Medical Center

Seoul, South Korea, 135-710

Recruiting

Ditmanson Medical Foundation Chia-Yi Christian Hospital

Chiayi City, Taiwan,

Recruiting

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, 807

Recruiting

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan, 83301