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Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME)","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)","B-SUPREME","Key Inclusion Criteria:\n\n1. Male or female between 18 and 65 years of age, with body mass index (BMI) of 18.0 to 35.0 kg\u002Fm2 (or minimun age by local regulatory requirements).\n2. HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2).\n3. HBsAg ≥LLOQ.\n4. HBV DNA ≥20,000 IU\u002FmL.\n5. A history of a clinical diagnosis of chronic HBV infection AND an ALT values of ≤8×ULN during screening.\n6. Must have the following chronic hepatitis B virus infection treatment status at screening:\n\n   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\n   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).\n\nKey Exclusion Criteria:\n\n1. Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.\n2. Positive for anti-HBs antibodies.\n3. History or current evidence of cirrhosis.\n4. Liver fibrosis that is classified as Metavir Score ≥F3 liver disease.\n5. History of, or current evidence of, hepatic decompensation.\n6. Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound.\n7. 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\n8. Exclusionary screening laboratory values include:\n\n   1. Aspartate aminotransferase (AST) \\>8×ULN,\n   2. Bilirubin (total, direct) \\>1.2×ULN (unless Gilbert's syndrome is suspected)\n   3. International Normalization Ratio (INR) \\>1.2×ULN","ALL","18 Years","65 Years",{"count":693,"type":694},200,"ESTIMATED","INTERVENTIONAL",[697],"PHASE2","This is a Phase 2 study to evaluate efficacy and safety of 48 weeks of oral once daily monotherapy with ALG-000184 versus tenofovir disproxil fumarate (TDF) for chronic HBV infection.",[700],"Chronic Hepatitis B Infection",[702,703,704,705,706,707,708],"Capsid Assembly Modulators","CAMs","CHB","HBV","Chronic Hepatitis B","Hepatitis B Infection","Hepatitis B","2026-04-29",{"date":711,"type":712},"2026-05-01","ACTUAL",{"date":714,"type":712},"2025-07-15",{"date":716,"type":694},"2028-08",{"name":5,"class":6},58]