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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Phase 1 and 2: Percentage of Participants With Treatment-emergent Adverse Events
Timeframe: Phase 1: First dose up to 44 weeks; Phase 2: First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up
Phase 1 and 2: Percentage of Participants With Treatment-emergent Serious Adverse Events
Timeframe: Phase 1: First dose up to 44 weeks; Phase 2: First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up
Phase 1 and 2: Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities
Timeframe: Phase 1: First dose up to 44 weeks; Phase 2: First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up
Phase 1: Serum Pharmacokinetic (PK) parameter; AUClast of GS-4321
Timeframe: First dose up to 24 Weeks
Phase 1: Serum PK Parameter: AUCinf
Timeframe: First dose up to 24 Weeks
Phase 1: Serum PK Parameter: Cmax
Timeframe: First dose up to 24 Weeks
Phase 1: Serum PK Parameter: Tmax
Timeframe: First dose up to 24 Weeks
Gilead Clinical Study Information Center
Phase 1: Serum PK Parameter: t1/2
Timeframe: First dose up to 24 Weeks
Phase 2: Proportion of Participants with Combined Response
Timeframe: Up to 96 Weeks