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RecruitingAccepts healthy volunteersPhase 1/Phase 2

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

Gilead Sciences · NCT07096193

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–69 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1, Phase 2
Target enrollment
200
US sites recruiting
5
Study start
July 31, 2025
Record last updated
August 27, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: GS-4321; GS-4321 Placebo; GS-4321

Conditions: Chronic Hepatitis Delta

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Investigative Site

    Anaheim, CA 92801

  • University of California, San Diego - Altman Clinical and Translational Research Institute

    La Jolla, CA 92093

  • University of Louisville, Clinical Trials Unit

    Louisville, KY 40202

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

    Baltimore, MD 21201

  • The New York-Presbyterian Hospital

    New York, NY 10021

Study contacts (from the official record)

  • Gilead Clinical Study Information Center · 1-833-445-3230 (GILEAD-0) · GileadClinicalTrials@gilead.com
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