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Study of AHB-171 in Chronic Hepatitis B Participants

2026年7月20日 更新者：Ausper Biopharma Co., Ltd.

An Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of AHB-171 Injection in Participants With Chronic Hepatitis B

The study adopts an open-label, multiple-dose design and aims to evaluate the efficacy and safety of AHB-171 Injection after multiple doses in treatment-naïve (HBeAg-negative/positive) and nucleos(t)ide analogue (NA)-treated (HBeAg-negative) participants with chronic hepatitis B (CHB)

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)

138

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

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:

  • Able to fully understand and sign the informed consent form (ICF).
  • Male or female participants, aged 18-65 years (inclusive).
  • Body mass index (BMI) meeting the predefined eligibility range.
  • Chronic hepatitis B (CHB) participants with HBsAg or HBV DNA positivity for ≥6 months at screening.
  • At screening, participants meeting predefined ranges of HBsAg, HBV DNA, and ALT according to prior nucleos(t)ide analogue (NA) treatment history (stable prior treatment or treatment-naive), and meeting corresponding prior antiviral treatment duration requirements.
  • Adopt effective contraceptive measures as required

Exclusion Criteria:

  • History of any severe systemic disease or malignancy other than chronic HBV infection which, in the opinion of the investigator, makes the subject unsuitable for study participation.
  • Prior history of solid organ or hematopoietic stem cell transplantation.
  • History of any other liver disease that the investigator considers unsuitable for trial.History of autoimmune disease or diseases with potential immune activation risk.
  • History or presence of hepatic decompensation at screening.
  • History of primary liver cancer, or diagnosis/suspected liver cancer at screening.
  • Imaging or histological evidence of significant liver fibrosis or cirrhosis within 12 months prior to screening, or a liver stiffness measurement indicative of significant fibrosis or cirrhosis at screening. Major trauma or major surgery within 12 weeks prior to screening
  • History of severe allergies (e.g., to ≥2 allergens) or severe allergy to any component of the study drug, or in the opinion of the investigator, makes the subject unsuitable for participation.
  • Severe infection requiring intravenous anti-infective therapy within 2 weeks prior to screening (excluding chronic HBV infection).
  • History of drug abuse, or alcoholism.
  • Blood donation or blood loss exceeding the specified volume within 12 weeks prior to screening, or planned blood donation during the trial period.
  • Use of immunosuppressants, immunomodulators, cytotoxic drugs, or biologics within 6 months prior to screening.
  • Use of any oligonucleotide drugs or interferon therapy within 12 months prior to screening.
  • Vaccination within 4 weeks prior to screening, or planned vaccination during the trial period.
  • Presence of tattoos, active skin diseases, or other conditions that may interfere with subcutaneous drug administration or observation of injection site reactions.
  • Clinically significant abnormal electrocardiogram (ECG) at screening.
  • Tested positive for HIV，HCV or active syphilis infection.
  • Uncontrolled hypertension at screening.
  • Clinically significant abnormal laboratory test as specified in protocol at screening.
  • Currently participating in another clinical trials, or within the washout period.
  • Any other condition or factor which, in the opinion of the investigator, makes the subject unsuitable for trial participation.

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：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：AHB-171 in Treatment CHB
药品：AHB-171 Injection
Subcutaneous injection
实验性的：AHB-171 in Naïve CHB
药品：AHB-171 Injection
Subcutaneous injection

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Proportion of participants with HBsAg <10 IU/mL and HBV DNA < LLOQ (10 IU/mL)
大体时间：Up to 90 days
Up to 90 days

次要结果测量

结果测量
措施说明
大体时间
Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ)
大体时间：Up to 90 days
Up to 90 days
Proportion of participants with HBsAg decline from baseline of <0.5, ≥0.5, ≥1.0, ≥1.5, ≥2.0, ≥3.0 log₁₀ IU/mL at each visi
大体时间：Up to 90 days
Up to 90 days
Proportion of participants with HBsAg <100 IU/mL, <10 IU/mL, <1 IU/mL at each visit
大体时间：Up to 90 days
Up to 90 days
Proportion of participants achieving HBsAg clearance (HBsAg <0.05 IU/mL) at each visit
大体时间：Up to 90 days
Up to 90 days
Proportion of participants with HBV DNA < LLOQ (10 IU/mL) at each visit
大体时间：Up to 90 days
Up to 90 days
Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ) at each visit
大体时间：Up to 90 days
Up to 90 days
Proportion of participants with anti-HBs seroconversion (HBsAg clearance and HBsAb >10 IU/L) at each visit
大体时间：Up to 90 days
Up to 90 days
Absolute or log change from baseline for HBsAg at each visit
大体时间：Up to 90 days
Up to 90 days
Absolute or log change from baseline for HBV RNA at each visit
大体时间：Up to 90 days
Up to 90 days
Absolute or log change from baseline for HBcrAg at each visit
大体时间：Up to 90 days
Up to 90 days
Absolute or log change from baseline for HBeAg at each visit
大体时间：Up to 90 days
Up to 90 days
Absolute or log change from baseline for HBeAb at each visit
大体时间：Up to 90 days
Up to 90 days
Proportion of participants with baseline ALT > ULN achieving ALT normalization, and time to ALT normalization
大体时间：Up to 90 days
Up to 90 days
Incidence and severity of treatment-emergent adverse events (TEAE) and serious adverse events (SAE)
大体时间：Up to 90 days
CTCAE will be used to describe severity.
Up to 90 days
Proportion of participants with clinically significant abnormalities in laboratory tests
大体时间：Up to 90 days
Up to 90 days
Proportion of participants with clinically significant abnormalities in ECG
大体时间：Up to 90 days
Up to 90 days
Proportion of participants with clinically significant abnormalities in physical examinations and vital signs
大体时间：Up to 90 days
Up to 90 days
Changes in ECG from baseline
大体时间：Up to 90 days
Up to 90 days
Proportion of participants with HBsAg decline ≥2.0 log₁₀ IU/mL
大体时间：Up to 90 days
Up to 90 days
Plasma concentration of AHB-171 at different time points
大体时间：Up to 90 days
Up to 90 days
Proportion of participants with detectable anti-drug antibody (ADA)
大体时间：Up to 90 days
Up to 90 days
Change of HBsAg (log₁₀ IU/mL) from baseline and maximum reduction at each visit
大体时间：Up to 90 days
Up to 90 days

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.

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24日

初级完成 (估计的)

2029年3月31日

研究完成 (估计的)

2029年5月31日

研究注册日期

首次提交

2026年6月2日

首先提交符合 QC 标准的

2026年6月2日

首次发布 (实际的)

2026年6月5日

研究记录更新

最后更新发布 (实际的)

2026年7月21日

上次提交的符合 QC 标准的更新

2026年7月20日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • AB-17-8003

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

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