A Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)

NCT ID: NCT07137910

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-27
• Study Completion Date: 2027-06-01

Brief Summary

This study is an open-label, multicenter phase II clinical study to evaluate the efficacy and safety of AHB-137 injection in participants with CHB previously treated with NA.

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Relevant drug treatment group

Group Type: EXPERIMENTAL

AHB-137

Intervention Type: DRUG

AHB-137 will be injected

No relevant drug treatment group

Group Type: EXPERIMENTAL

AHB-137

Intervention Type: DRUG

AHB-137 will be injected

Interventions

AHB-137

AHB-137 will be injected

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Voluntarily participate in the study and sign the informed consent form;
• 18-65 years of age (including boundary values) ;
• Body mass index met the requirements;
• Participants with CHB who are HBsAg or HBV DNA positive for at least 6 months;
• Meet the relevant requirements for prior medications;
• HBsAg and HBV DNA and liver function indicators meet the requirements;
• Effective contraception as required;

Exclusion Criteria

• Uncontrolled and stable clinically significant abnormalities other than a history of CHB infection;
• Associated liver disease;
• Any serious infection other than CHB infection requires intravenous anti-infective therapy;
• HCV RNA positive, HIV antibody positive, syphilis positive;
• Abnormal laboratory results;
• Diseases associated with vascular inflammatory conditions;
• QT interval corrected heart rate (Fridericia method) abnormal;
• History of malignancy or ongoing assessment of possible malignancy;
• History of allergies, or allergic constitution;
• Participants with recent major trauma or major surgery, or planning surgery;
• Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
• Prior/current use of prohibited medications;
• Inappropriate for participation in this trial as judged by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ausper Biopharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junqi Niu

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Yanhua Ding

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

AusperBio Investigational Site

Jilin, Changchun, China

Countries

China

Central Contacts

Lu

Role: CONTACT

clinicaltrial@ausperbio.com

0571-86959519

Facility Contacts

Lu

Role: primary

clinicaltrial@ausperbio.com

0571-86959519

Other Identifiers

AB-10-8009

Identifier Type: -

Identifier Source: org_study_id