NCT07635186RecruitingPhase 2
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.
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- First submitted
- 28 May 2026
- Start date
- 5 Jun 2026
- Primary completion date
- 20 Jun 2027
- Lead sponsor
- Ausper Biopharma Co., Ltd.
- Diseases
- Hepatitis B
- NCT number
- NCT07635186
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 320
- From 5 Jun 2026 to the primary completion date, 20 Jun 2027
- 23 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Major trauma or major surgery within 3 months prior to screening, or planned surgery during the trial.
- 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 have received any antisense oligonucleic acid, siRNA, capsid assembly modulator (CAM) antiviral drug used to treat chronic hepatitis B.
Other illness
- Uncontrolled and stable clinically significant abnormalities other than a history of chronic HBV infection.
- 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).
- 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.
- Allergic to AHB-137 ingredients, or history of drug allergy or other allergies.
- Any other circumstances or conditions in which, in the opinion of the investigator, the participant is inappropriate for participation in this trial.
Lab values
- 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.
Other
- Significant fibrosis or cirrhosis, or liver stiffness value (LSM) \> 9.0 kPa at screening.
- Participants are participating in another clinical trial or failing to wash out as required.
- Participants that require regular long-term anticoagulants.
- Abnormal thyroid function.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.