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ACTIVE NOT RECRUITING
NCT06115993
PHASE1/PHASE2

A Study to Evaluate the Safety and Efficacy of AHB-137 in Healthy Participants and HBeAg-negative Chronic Hepatitis B (CHB) Patients

Sponsor: Ausper Biopharma Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of AHB-137 subcutaneous injection in healthy participants after single and multiple doses, and evaluate the preliminary efficacy of AHB-137 in CHB participants after up to 24 weeks of treatment as a proof-of-concept.

Official title: A Phase I/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Single Ascending Doses and Multiple Doses of AHB-137 in Healthy Participants and HBeAg-negative CHB Patients Receiving Stable Nucleos(t)Ide Analogues (NAs) Treatment

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

129

Start Date

2023-08-03

Completion Date

2026-01

Last Updated

2025-09-25

Healthy Volunteers

Yes

Interventions

DRUG

AHB-137 injection

AHB-137 injection will be administered subcutaneously.

DRUG

Placebo

Placebo will be administered subcutaneously.

Locations (3)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

Nanfang Hospital, Southern Medical University

Guangzhou, China

The First Hospital of Jilin University

Jilin, China