NCT06993480

A Study to Evaluate the Antiviral Activity and Immune Response of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)

A Single-Center, Open-Label Phase II Clinical Study to Evaluate the Antiviral Activity and Immune Responses of AHB-137 Injection in Participants With CHB Treated With Nucleos (t) Ide Analogues

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ausper Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

AB-10-8005 is a single-center, open-label Phase II clinical study to evaluate the antiviral activity and immune responses of AHB-137 injection in participants with CHB treated with nucleos (t) ide analogues.

Detailed description

The study is to evaluate the antiviral activity and immune response of AHB-137 injection in participants with CHB treated with nucleos(t)ide analogues. The study is proposed to enroll 20-30 patients, with a total study duration of approximately 56 weeks per participants, including a screening period (up to 4 weeks), a clinical study lead-in period (approximately 4 weeks), an AHB-137 treatment period (24 weeks) and a follow-up period (24 weeks).

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	AHB-137	AHB-137 300 mg will be injected subcutaneously once a week (total 24 weeks).

Timeline

• Start date: 2025-06-18
• Primary completion: 2026-06-30
• Completion: 2026-12-01
• First posted: 2025-05-28
• Last updated: 2025-12-29

Locations

1 site across 1 country: China