Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1: GS-4321
Participants will receive single escalating doses of GS-4321.
  • Drug: GS-4321
    Administered subcutaneous (SC) or intravenously IV
Placebo Comparator
Phase 1: Placebo
Participants will receive placebo to match the single escalating doses of GS-4321
  • Drug: GS-4321 Placebo
    Administered SC
Experimental
Phase 2: GS-4321
Participants will receive multiple escalating doses of GS-4321 up to 96 weeks.
  • Drug: GS-4321
    Administered SC

Recruiting Locations

Investigative Site
Anaheim 5323810, California 5332921 92801

More Details

Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.