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

Open to people ages 18-69

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.

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.