A 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 (B-SUPREME)

Eligibility Criteria

• 1. Male or female between 18 and 65 years of age, with body mass index (BMI) of 18.0 to 35.0 kg/m2.
• 2. HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2).
• 3. HBsAg ≥100 IU/mL.
• 4. HBV DNA ≥20,000 IU/mL.
• 5. A history of a clinical diagnosis of chronic HBV infection AND an ALT values of ≤8×ULN during screening.
• 6. Must have the following chronic hepatitis B virus infection treatment status at screening:
• 1. Have never received treatment with HBV antiviral medicines (NA, interferon) or investigational anti-HBV agents including a CAM \[i.e., Treatment Naïve (TN) subjects\], OR
• 2. Have not been on treatment with approved (NA, interferon) or investigational HBV antiviral medicines (e.g., antisense oligonucleotides or small interfering RNAs) within 6 months or 5 half-lives (whichever is longer) prior to randomization (i.e., Currently Not Treated (CNT) subjects).
• 1. Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.
• 2. Positive for anti-HBs antibodies.
• 3. History or current evidence of cirrhosis.
• 4. Liver fibrosis that is classified as Metavir Score ≥F3 liver disease.
• 5. History of, or current evidence of, hepatic decompensation.
• 6. Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound.
• 7. Having received an investigational medicinal product or device within 4 weeks (or 5 half-lives, whichever is longer) before the planned first dose of study drug
• 8. Exclusionary screening laboratory values include:
• 1. Aspartate aminotransferase (AST) \>8×ULN,
• 2. Bilirubin (total, direct) \>1.2×ULN (unless Gilbert's syndrome is suspected)
• 3. International Normalization Ratio (INR) \>1.2×ULN