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

Conditions

• Chronic Hepatitis Delta

Eligibility Criteria

Sex

ALL

Age

18 Years - 69 Years

Healthy Volunteers

Accepted

Interventions

• GS-4321 — DRUG
  Administered subcutaneous (SC) or intravenously IV
• GS-4321 Placebo — DRUG
  Administered SC
• GS-4321 — DRUG
  Administered SC

Study Details

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.

Key Dates

Start date

Jul 31, 2025

Status verified

Jun 2026

Primary completion

Jan 31, 2030

Completion

Jan 31, 2030

Study Design

Enrollment

200 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1: GS-4321
  Participants will receive single escalating doses of GS-4321.
• Placebo Comparator: Phase 1: Placebo
  Participants will receive placebo to match the single escalating doses of GS-4321
• Experimental: Phase 2: GS-4321
  Participants will receive multiple escalating doses of GS-4321 up to 96 weeks.

Primary Outcome Measure

Phase 1 and 2: Percentage of Participants With Treatment-emergent Adverse Events [ Time Frame: Phase 1: First dose up to 44 weeks; Phase 2: First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up ]

Central Contacts

• Gilead Clinical Study Information Center
  1-833-445-3230 (GILEAD-0)
  [email protected]

Locations (4)

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