NCT07635186招募中2 期
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.23 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2026年6月5日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 320
- 试验地点
- 23
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo will be administered subcutaneously.
干预措施: Placebo (Drug)
AHB-137
Experimental
AHB-137 will be administered subcutaneously.
干预措施: AHB-137 (Drug)
研究者
研究点 (23)
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