NCT07635186|RecruitingPhase 2DMC

A Study to Evaluate AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Clinical Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B.

Ausper Biopharma Co., Ltd.ClinicalTrials.gov

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1 other identifier

AB-10-8016

Study Type

interventional

Target

320

Locations

1 country

Sites

Timeline

RegisteredJun 2026

StartedJun 2026

CompletionJun 2028

Brief Summary

This study is a randomized, double-blind, placebo-controlled, multicenter phase 2 study to assess the efficacy and safety of AHB-137 injection in treatment-naïve participants with chronic hepatitis B.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

320

participants targeted

Target at P75+ for phase_2

Timeline

23mo left

Started Jun 2026

Geographic Reach

1 country

34 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

Study Progress8%

Jun 2026Jun 2028

First Submitted

Initial submission to the registry

May 28, 2026

Completed

8 days until next milestone

Study Start

First participant enrolled

June 5, 2026

Completed

4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2027

Expected

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2028

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

May 28, 2026

Last Update Submit

July 28, 2026

Conditions

Chronic Hepatitis B

Keywords

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (2)

HBV DNA < lower limit of quantitation (LLOQ), 10 IU/mL, HBsAg < limit of detection (LOD), 0.05 IU/mL with or without hepatitis B virus surface antibody (HBsAb) 24 weeks after discontinuation of all chronic hepatitis B treatment.
Up to 48 weeks.
Highly sensitive HBsAg < 0.005 IU/mL and HBV DNA < LLOQ (10 IU/mL) at the end of treatment.
Up to 48 weeks.

Secondary Outcomes (20)

HBV DNA < LLOQ, 10 IU/mL, and HBsAg < 10 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment.
Up to 48 weeks.
HBV DNA < LLOQ 24 weeks after discontinuation of all chronic hepatitis B treatment.
Up to 48 weeks.
HBV DNA < LLOQ and HBsAg < 100 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment.
Up to 48 weeks.
HBsAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment.
Up to 48 weeks.
HBeAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment.
Up to 48 weeks.
+15 more secondary outcomes

Study Arms (2)

AHB-137

EXPERIMENTAL

AHB-137 will be administered subcutaneously.

Drug: AHB-137

Placebo

PLACEBO COMPARATOR

Placebo will be administered subcutaneously.

Drug: Placebo

Interventions

AHB-137DRUG

AHB-137 will be administered subcutaneously.

AHB-137

PlaceboDRUG

Placebo will be administered subcutaneously.

Placebo

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Volunteer to participate and sign the informed consent form, and are willing to complete the study in accordance with the requirements of the protocol.
Aged 18-65 years (including boundary values).
Body mass index between the range of 18-32 kg/m2 (inclusive boundary values).
HBsAg or HBV DNA positive for ≥ 6 months at screening and no antiviral treatment with interferon or nucleoside analogue.
HBsAg and HBV DNA values met protocol requirements at screening.
ALT \< 3xULN at screening.
Use highly effective contraception as required.

You may not qualify if:

Uncontrolled and stable clinically significant abnormalities other than a history of chronic HBV infection.
Participants with other clinically significant liver diseases, previous/current manifestations of hepatic decompensation, and a history of extrahepatic diseases that may be related to HBV immune status.
Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to randomization.
Hepatitis C virus (HCV) infection or \< 12 months from cure at screening (HCV RNA positive within 12 months), human immunodeficiency virus (HIV) positive at screening, and syphilis positive (treponema pallidum antibody positive).
Significant fibrosis or cirrhosis, or liver stiffness value (LSM) \> 9.0 kPa at screening.
Participants with confirmed or suspected liver cancer who have a history of malignancy within the past 5 years or are undergoing assessment for a possible malignancy.
Laboratory test results do not meet the criteria.
Prior/current autoimmune disease, history of vasculitis, or presence of signs, symptoms, or laboratory tests of underlying vasculitis.
Fridericia ' s formula corrected QT interval (QTcF) ≥ 450 msec for male participants and ≥ 470 msec for female participants at screening.
Allergic to AHB-137 ingredients, or history of drug allergy or other allergies.
Major trauma or major surgery within 3 months prior to screening, or planned surgery during the trial.
Participants are participating in another clinical trial or failing to wash out as required.
Current use or use of any immunosuppressive medication (e.g. prednisone) within 3 months prior to screening, except for short courses (≤ 2 weeks) or use of topical/inhaled steroids;Those who have used immunomodulators within 3 months prior to screening;Those who have used cytotoxic drugs within 6 months prior to screening;History of vaccination within 1 month prior to screening or a live vaccination plan during the trial.
Participants that require regular long-term anticoagulants.
Abnormal thyroid function.
+2 more criteria

Contact the study team to confirm eligibility.