AHB-137 injection in people with chronic hepatitis B

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled phase 2 trial evaluating the safety and efficacy of AHB-137 injection in treatment-naïve adults with chronic hepatitis B. Eligible participants are 18 to 65 years old with confirmed HBV infection and no prior antiviral therapy, enrolled at sites in Beijing and Chongqing. Participants will receive either AHB-137 or placebo and will be monitored for liver-related safety and antiviral responses over the study period. The trial aims to determine whether AHB-137 can reduce HBV markers and improve liver function without unacceptable safety risks.

Why it matters

Who can join: the full rules

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.

Where it's running

• AusperBio Investigational Site
  Beijing, Beijing Municipality, China Recruiting
• AusperBio Investigational Site
  Chongqing, Chongqing Municipality, China Recruiting
• The Second Affiliated Hospital of Chongqing Medical University
  Chongqing, Chongqing Municipality, China Recruiting
• AusperBio Investigational Site
  Xiamen, Fujian, China Recruiting
• AusperBio Investigational Site
  Guangzhou, Guangdong, China Recruiting
• AusperBio Investigational Site
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Yunqing Qiu — First Affiliated Hospital of Zhejiang University
• Study coordinator: Lu
• Email: clinicaltrial@ausperbio.com
• Phone: 0571-86959519

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• AHB-137 injection pharmacokinetics and safety in people with mild to moderate liver dysfunction and normal liver function

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• ASC22 plus pegylated interferon alfa to try to achieve a functional cure for chronic hepatitis B

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.