NCT05717686

A Study Evaluating AHB-137 in Healthy Participants and Participants with Chronic Hepatitis B

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AHB-137 with Single Ascending Doses and Multiple Doses in Healthy Volunteers and Initial Efficacy in Chronic Hepatitis B Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: AusperBio Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of AHB-137 subcutaneous injection in healthy volunteers and in chronic hepatitis B (CHB) patients after single and multiple doses. In addition, the study will evaluate the initial antiviral efficacy of AHB-137 in CHB patients following a multiple dosing regimen.

Detailed description

This is a first-in-human study of AHB-137, consisting of four parts. Parts A and B are randomized, double-blinded, placebo-controlled studies designed to assess the safety, tolerability, pharmacokinetics of AHB-137 following subcutaneous injection in healthy volunteers at a 6:2 ratio of AHB-137 to placebo. Part A is a single-ascending dose (SAD) study, and Part B is a single-ascending dose (SAD) study, and Part B is a multiple dose (MD) study. Part C is an open label MD study with up to 6 CHB patients. Part D is a double blinded study in CHB patients at a 4:1 ratio to receive AHB-137 or placebo. Study advancement to subsequent parts/cohorts will require satisfactory interim reviews of available cumulative safety data by the Safety Review Committees (SRC), using the safety criteria and review procedures described in the protocol.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	AHB-137 injection	AHB-137 will be administered
DRUG	Placebo	Placebo will be administered

Timeline

• Start date: 2023-02-28
• Primary completion: 2025-01-07
• Completion: 2025-01-07
• First posted: 2023-02-08
• Last updated: 2025-02-14

Locations

9 sites across 4 countries: United States, Hong Kong, New Zealand, Taiwan

Regulatory

• FDA-regulated drug study