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

2026年7月28日 更新者：Ausper Biopharma Co., Ltd.

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.

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

320

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国
        • 招聘中
        • AusperBio Investigational Site
        • 首席研究员：
          • Yao Xie
        • 接触：
    • Chongqing Municipality
      • Chongqing、Chongqing Municipality、中国
        • 招聘中
        • The Second Affiliated Hospital of Chongqing Medical University
        • 首席研究员：
          • Peng Hu
        • 接触：
      • Chongqing、Chongqing Municipality、中国
        • 招聘中
        • AusperBio Investigational Site
        • 接触：
        • 首席研究员：
          • Guicheng Wu
    • Fujian
      • Xiamen、Fujian、中国
        • 招聘中
        • AusperBio Investigational Site
        • 首席研究员：
          • Qianguo Mao
        • 接触：
    • Guangdong
      • Guangzhou、Guangdong、中国
        • 招聘中
        • AusperBio Investigational Site
        • 接触：
        • 首席研究员：
          • Xingfei Pan
      • Jiangmen、Guangdong、中国
        • 招聘中
        • AusperBio Investigational Site
        • 接触：
        • 首席研究员：
          • Gang He
      • Meizhou、Guangdong、中国
        • 招聘中
        • AusperBio Investigational Site
        • 接触：
        • 首席研究员：
          • Tianhuang Liu
      • Qingyuan、Guangdong、中国
        • 招聘中
        • AusperBio Investigational Site
        • 首席研究员：
          • Xi He
        • 接触：
      • Shenzhen、Guangdong、中国
        • 招聘中
        • AusperBio Investigational Site
        • 首席研究员：
          • Guoxin Hu
        • 接触：
    • Guangxi
      • Liuzhou、Guangxi、中国
        • 招聘中
        • AusperBio Investigational Site
        • 首席研究员：
          • Jiaguang Hu
        • 接触：
    • Hubei
      • Wuhan、Hubei、中国
        • 招聘中
        • AusperBio Investigational Site
        • 首席研究员：
          • Kai Dai
        • 接触：
      • Yichang、Hubei、中国
        • 招聘中
        • AusperBio Investigational Site
        • 接触：
        • 首席研究员：
          • Xiaolin Zhou
    • Hunan
      • Changsha、Hunan、中国
        • 招聘中
        • AusperBio Investigational Site
        • 首席研究员：
          • Jing Ma
        • 接触：
    • Jiangsu
      • Nanjing、Jiangsu、中国
        • 招聘中
        • AusperBio Investigational Site
        • 首席研究员：
          • Jie Li
        • 接触：
    • Jiangxi
      • Nanchang、Jiangxi、中国
        • 招聘中
        • AusperBio Investigational Site
        • 首席研究员：
          • Xiaoping Wu
        • 接触：
    • Jilin
      • Changchun、Jilin、中国
        • 招聘中
        • AusperBio Investigational Site
        • 首席研究员：
          • Yanhang Gao
        • 接触：
    • Liaoning
      • Shenyang、Liaoning、中国
        • 招聘中
        • AusperBio Investigational Site
        • 首席研究员：
          • Yang Ding
        • 接触：
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国
        • 招聘中
        • AusperBio Investigational Site
        • 首席研究员：
          • Liang Chen
        • 接触：
    • Shanxi
      • Xi’an、Shanxi、中国
        • 招聘中
        • AusperBio Investigational Site
        • 首席研究员：
          • Shuangsuo Dang
        • 接触：
    • Sichuan
      • Chengdu、Sichuan、中国
        • 招聘中
        • AusperBio Investigational Site
        • 首席研究员：
          • Li Zhu
        • 接触：
    • Yunan
      • Kunming、Yunan、中国
        • 招聘中
        • AusperBio Investigational Site
        • 首席研究员：
          • Hui Li
        • 接触：
    • Zhejiang
      • Hangzhou、Zhejiang、中国
        • 招聘中
        • The First Affiliated Hospital of Zhejiang University school of medicine
        • 首席研究员：
          • Yunqing Qiu
        • 接触：
      • Hangzhou、Zhejiang、中国
        • 招聘中
        • AusperBio Investigational Site
        • 首席研究员：
          • Guoping Sheng
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：AHB-137
AHB-137 will be administered subcutaneously.
药品：AHB-137
AHB-137 will be administered subcutaneously.
安慰剂比较：Placebo
Placebo will be administered subcutaneously.
药品：安慰剂
安慰剂将皮下给药。

研究衡量的是什么？

主要结果指标

结果测量
大体时间
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.
大体时间：Up to 48 weeks.
Up to 48 weeks.
Highly sensitive HBsAg < 0.005 IU/mL and HBV DNA < LLOQ (10 IU/mL) at the end of treatment.
大体时间：Up to 48 weeks.
Up to 48 weeks.

次要结果测量

结果测量
措施说明
大体时间
HBV DNA < LLOQ, 10 IU/mL, and HBsAg < 10 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment.
大体时间：Up to 48 weeks.
Up to 48 weeks.
HBV DNA < LLOQ 24 weeks after discontinuation of all chronic hepatitis B treatment.
大体时间：Up to 48 weeks.
Up to 48 weeks.
HBV DNA < LLOQ and HBsAg < 100 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment.
大体时间：Up to 48 weeks.
Up to 48 weeks.
HBsAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment.
大体时间：Up to 48 weeks.
HBsAg seroconversion : serum HBsAg<LOD, and at the same time or subsequently, HBsAb>10 IU/L.
Up to 48 weeks.
HBeAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment.
大体时间：Up to 48 weeks.
HBeAg seroconversion:HBeAg negative, with simultaneous or subsequent positivity for HBeAb.
Up to 48 weeks.
Proportion of participants who discontinued all chronic hepatitis B treatment at the end of treatment.
大体时间：Up to 48 weeks.
Up to 48 weeks.
HBV DNA < LLOQ and HBsAg < LOD rate and HBV DNA < LLOQ and HBsAg < 10 IU/mL rate by visit.
大体时间：Up to 48 weeks.
Up to 48 weeks.
HBsAg, HBeAg seroconversion rates by visit.
大体时间：Up to 48 weeks.

HBsAg seroconversion: serum HBsAg<LOD, and at the same time or subsequently, HBsAb>10 IU/L.

HBeAg seroconversion: HBeAg negative, with simultaneous or subsequent positivity for HBeAb.
Up to 48 weeks.
Test Values of Virological Parameters.
大体时间：Up to 48 weeks.
HBsAb, HBsAg, HBV DNA values and changes from baseline at each visit.
Up to 48 weeks.
Time to first achievement of HBsAg and first HBeAg seroconversion.
大体时间：Up to 48 weeks.

HBsAg seroconversion: serum HBsAg<LOD, and at the same time or subsequently, HBsAb>10 IU/L.

HBeAg seroconversion: HBeAg negative, with simultaneous or subsequent positivity for HBeAb.
Up to 48 weeks.
Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline.
大体时间：Up to 48 weeks.
Response options range from 1 to 5 with higher scores indicating more severe impact .
Up to 48 weeks.
Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline.
大体时间：Up to 48 weeks.
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the participant's health state.
Up to 48 weeks.
Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA.
大体时间：Up to 48 weeks.
Up to 48 weeks.
Change from baseline in alanine aminotransferase (ALT) and noninvasive assessment of liver fibrosis at each visit.
大体时间：Up to 48 weeks.
Up to 48 weeks.
Time to normalization of ALT without rescue therapy (for participants with abnormal baseline ALT).
大体时间：Up to 48 weeks.
Up to 48 weeks.
AHB-137 resistance analysis.
大体时间：Up to 48 weeks.
Method: Sequencing of HBV DNA/RNA.
Up to 48 weeks.
Proportion of participants who are HBeAb positive and HBeAg negative, and the test values of HBsAb, HBsAg and HBV DNA meet certain conditions.
大体时间：Up to 48 weeks.
Up to 48 weeks.
Safety: number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.
大体时间：Up to 48 weeks.
Examination including laboratory examination, electrocardiogram (ECG) examination.
Up to 48 weeks.
Proportion of participants with positive anti-drug antibody (ADA) and ADA level at each visit.
大体时间：Up to 48 weeks.
Up to 48 weeks.
Plasma drug concentration of AHB-137.
大体时间：Up to 48 weeks.
Up to 48 weeks.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ausper Biopharma Co., Ltd.

调查人员

  • 首席研究员：Peng Hu、The Second Affiliated Hospital of Chongqing Medical University
  • 首席研究员：Yunqing Qiu、Zhejiang University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月5日

初级完成 (估计的)

2027年6月20日

研究完成 (估计的)

2028年6月20日

研究注册日期

首次提交

2026年5月28日

首先提交符合 QC 标准的

2026年6月3日

首次发布 (实际的)

2026年6月9日

研究记录更新

最后更新发布 (实际的)

2026年7月29日

上次提交的符合 QC 标准的更新

2026年7月28日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • AB-10-8016

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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