A Study of ALG-000184 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects

Summary

The goal of this clinical trial is to learn if ALG-000184 is safe, well-tolerated, and works to treat chronic hepatitis B virus (HBV) infection. The main questions it aims to answer are: Is ALG-000184 safe and well-tolerated when given alone or with entecavir (a standard HBV treatment)? Does ALG-000184 reduce HBV viral levels in the blood of patients with chronic hepatitis B? How does the body process ALG-000184 (pharmacokinetics)? Researchers will compare ALG-000184 to placebo (a look-alike substance that contains no drug) to see if ALG-000184 works better at reducing hepatitis B viral markers. The study has five parts: Parts 1 and 2: Healthy volunteers will receive single or multiple doses of ALG-000184 or placebo Part 3: Patients with chronic hepatitis B will receive ALG-000184 or placebo daily for 28 days Part 4: Patients with chronic hepatitis B will receive ALG-000184 or placebo combined with entecavir for 12 weeks (may be extended up to 96 weeks) Part 5: Additional groups of patients with chronic hepatitis B will receive ALG-000184 with entecavir for 12 weeks (may be extended up to 96 weeks) Participants will: Take study medication orally as directed Visit the clinic regularly for blood tests, physical examinations, and other safety assessments Have their HBV viral markers measured to determine if the treatment is working

Timeline

Start

2020-10-22

Primary completion

2025-06-16

Completion

2025-06-16

Publications

• Yuen MF, Agarwal K, Jucov A, Hou J, Niu J, Ding Y, Haceatrean A, Liang X, Xu J, Wu M, Le K, Lin TI, Blatt L, Chanda S, Fry J, Gane E. ALG-000184 (pevifoscorvir sodium) monotherapy in participants with chronic HBV infection: a phase 1, multicentre, randomised, dose escalation trial. Lancet Gastroenterol Hepatol. 2026 Mar;11(3):218-231. doi: 10.1016/S2468-1253(25)00293-6. Epub 2026 Jan 16.
• Gane E, Schwabe C, Wu M, Lin TI, Blatt L, Fry J, Chanda S, Le K. A Phase 1 study of the safety, tolerability, and pharmacokinetics of ALG-000184 (pevifoscorvir sodium), a novel Class E capsid assembly modulator, in healthy participants. Antivir Ther. 2025 Dec;30(6):13596535251392955. doi: 10.1177/13596535251392955. Epub 2025 Nov 21.
• Li C, Wu M, Zhang H, Mai J, Yang L, Ding Y, Niu J, Mao J, Wu W, Zhang D, Tang Y, Yan W. Safety, Tolerability, and Pharmacokinetics of the Novel Hepatitis B Virus Capsid Assembly Modulator GST-HG141 in Healthy Chinese Subjects: a First-in-Human Single- and Multiple-Dose Escalation Trial. Antimicrob Agents Chemother. 2021 Sep 17;65(10):e0122021. doi: 10.1128/AAC.01220-21. Epub 2021 Jul 19.

Drugs

Indications