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RecruitingPhase 1Phase 2NCT07096193

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

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

Sponsor

Gilead Sciences

Enrollment

107 participants

Start Date

Jul 31, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Hepatitis Delta

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria10

  • 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 ) \> 100 IU/mL at screening.
  • Alanine aminotransferase (ALT) level \> 1 × Upper limit of normal (ULN), but \< 10 × ULN at screening.

Exclusion Criteria8

  • 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.
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Interventions

DRUGGS-4321

Administered subcutaneous (SC) or intravenously IV

DRUGGS-4321 Placebo

Administered SC

DRUGGS-4321

Administered SC

Locations(12)

Investigative Site

Anaheim, California, United States

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

Baltimore, Maryland, United States

The New York-Presbyterian Hospital

New York, New York, United States

IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba"

Chinsinau, Moldova

PMSI Clinical Republican Hospital "Timofei Mosneaga"

Chisinau, Moldova

Infectious Diseases Institutul National De Boli Infectioase Prof. Matei Bals

Bucharest, Romania

Korea University Ansan Hospital

Ansan-si, South Korea

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

Bucheon-si, South Korea

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

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

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NCT07096193