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

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.

Eligibility

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Participants that have received any antisense oligonucleic acid, siRNA, capsid assembly modulator (CAM) antiviral drug used to treat chronic hepatitis B.
* Any other circumstances or conditions in which, in the opinion of the investigator, the participant is inappropriate for participation in this trial.

Conditions2

Interventions1

Related trials

• A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs — Ausper Biopharma Co., Ltd.
• A Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB) — Ausper Biopharma Co., Ltd.
• Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region — AusperBio Therapeutics Inc.

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