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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2029-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Hepatitis Delta

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Phase 1: GS-4321

Participants will receive single escalating doses of GS-4321.

Group Type EXPERIMENTAL

GS-4321

Intervention Type DRUG

Administered subcutaneous (SC) or intravenously IV

Phase 1: Placebo

Participants will receive placebo to match the single escalating doses of GS-4321

Group Type PLACEBO_COMPARATOR

GS-4321 Placebo

Intervention Type DRUG

Administered SC

Phase 2: GS-4321

Participants will receive multiple escalating doses of GS-4321 up to 96 weeks.

Group Type EXPERIMENTAL

GS-4321

Intervention Type DRUG

Administered SC

Interventions

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GS-4321

Administered subcutaneous (SC) or intravenously IV

Intervention Type DRUG

GS-4321 Placebo

Administered SC

Intervention Type DRUG

GS-4321

Administered SC

Intervention Type DRUG

Eligibility Criteria

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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes