A Randomized, Double-Blind, Active-Controlled Multicenter Phase 2 Study Evaluating the Efficacy and Safety of ALG-000184 Compared with Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg-Negative Adult Subjects with Chronic Hepatitis B Virus Infection (B-SUPREME)

Chronic Hepatitis B Virus Infection

Part 1 (HBeAg positive): Plasma HBV DNA < LLOQ (10 IU/mL, TD [target detected] or target not detected [TND])at Week 48, Part 2 (HBeAg negative): Plasma HBV DNA < LLOQ (10 IU/mL, TND) at Week 48

Safety will be assessed by monitoring treatment-emergent adverse events, physical examinations, vital signs, 12-lead electrocardiograms (ECGs), and clinical laboratory results (including chemistry, blood coagulation, hematology, and urinalysis)., Plasma HBV DNA level at Week 48 categorized according to one of the following ordinal categories: HBV DNA ≥ LLOQ, HBV DNA < LLOQ (TD), and HBV DNA < LLOQ (TND), Plasma HBV DNA < LLOQ (TD or TND) at various time points during the 48-week dosing period (Part 1 only), Plasma HBV DNA < LLOQ (TND) at various time points during the 48-week dosing period (Part 2 only), Change from baseline in plasma HBV DNA at various time points during the 48-week dosing period, Time to plasma HBV DNA < LLOQ (TD or TND) (Part 1 only), Time to plasma HBV DNA < LLOQ (TND) (Part 2 only), Serum HBV RNA < LLOQ at various time points during the 48-week dosing period, Change from baseline in serum HBV RNA at various time points during the 48-week dosing period, Time to serum HBV RNA < LLOQ, Subjects with abnormal ALT at baseline who have normal ALT at Week 48, Emergence of treatment-associated mutations in the HBV genome during the 48-week dosing period and the 48- to 96-week dosing period, PK parameters of ALG-001075 in plasma, including, but not limited to: Ctrough (predose), Tmax, Cmax, AUCss, and half-life, as applicable.

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