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A Clinical Study Evaluating the Pharmacokinetic Characteristics and Safety of AHB-137 Injection in Participants With Mild to Moderate Liver Dysfunction and Those With Normal Liver Function.

2026年7月27日 更新者：Ausper Biopharma Co., Ltd.
A clinical study evaluating the pharmacokinetic characteristics and safety of AHB-137 injection in participants with mild to moderate liver dysfunction and those with normal liver function.

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)

32

阶段

  • 阶段1

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
    • Chongqing Municipality
      • Chongqing、Chongqing Municipality、中国
    • Henan
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国
        • 招聘中
        • Huashan Hospital Fudan University
        • 首席研究员：
          • Jing Zhang
        • 接触：
        • 首席研究员：
          • Yuxian Huang
    • Sichuan
      • Chengdu、Sichuan、中国
    • Zhejiang

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

是的

描述

Inclusion Criteria:

  • Voluntarily participate in the study, sign an informed consent form before the study and be able to complete the study according to the requirements of the protocol;
  • At the time of signing the informed consent form, male or female participants aged 18-65 years (including threshold values);
  • Body mass index meets the criteria;
  • Take effective contraceptive measures as required;
  • Participants with liver function impairment need to meet certain liver function assessments;
  • Participants with normal liver function should meet certain age, weight, and gender requirements to match those with liver function impairment, and should also undergo certain physical and laboratory tests.

Exclusion Criteria:

  • Diagnosed or suspected liver cancer participants who have undergone liver transplantation;
  • History of vasculitis or presence of signs and symptoms of potential vasculitis or laboratory tests;
  • Unstable control of hypertension or diabetes, progressive nervous system disease, history of immune related extrahepatic diseases, and unstable cardiac function;
  • Participants with a history of malignant tumors or undergoing malignant tumor assessment;
  • Screening for participants who have undergone significant trauma or surgery within the previous 3 months, as well as those who plan to undergo surgery;
  • Participants with thyroid dysfunction who are not suitable for inclusion in the study;
  • Allergic or allergic constitution to AHB-137;
  • Long term regular receipt of anticoagulant or antiplatelet drugs is required;
  • Those who have received any antisense oligonucleotide drugs or have been treated with siRNA drugs or interferon within the 12 months prior to screening;
  • Currently using or using any immunosuppressive medication within the past 3 months prior to screening, except for short-term use or the use of topical/inhaled steroids; Individuals who have used immunomodulators and cytotoxic drugs within the 6 months prior to administration;
  • Those who have a history of vaccination or a plan to receive live vaccines within one month before administration, those who have used creatine containing fitness supplements 14 days before administration, and those who have used albumin 14 days before administration;
  • HIV, Syphilis positive ;
  • Those who are participating in another clinical trial and have not been eluted as required;
  • Positive results in urine drug screening and alcohol breath screening tests during screening;
  • Those who drink excessively and consume prohibited foods and beverages before administration;
  • Participants who have donated blood (or lost blood) ≥ 400 ml, received whole blood, or used red blood cell suspension within the past 3 months prior to screening; Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection;
  • Long term regular vigorous exercise or intense exercise within 48 hours before screening;
  • Any other circumstances or conditions that the researcher deems unsuitable for the subject to participate in this study;
  • Diseases that need to be excluded according to the merger plan for patients with abnormal liver function;
  • The laboratory test results do not meet the requirements of the protocol;
  • Participants with normal liver function who have a history of chronic liver disease or known liver or biliary abnormalities;
  • Participants with normal liver function who have used traditional Chinese medicine or other systemic medications with potential liver toxicity 14 days before administration;
  • Participants with normal liver function and abnormal QTcF values.

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：Part1: Child-Pugh B group
药品：AHB-137 injection
Single use subcutaneous injection
实验性的：Part2: Child-Pugh A group
药品：AHB-137 injection
Single use subcutaneous injection
实验性的：Part1:Participants with normal liver function group
药品：AHB-137 injection
Single use subcutaneous injection
实验性的：Part2:Participants with normal liver function group
药品：AHB-137 injection
Single use subcutaneous injection

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Key PK parameters of AHB-137 injection after single subcutaneous administration: peak concentration (Cmax)
大体时间：Up to day 29
Up to day 29
Key PK parameters of AHB-137 injection after single subcutaneous administration: area under the drug time curve from 0 to infinity (AUC)
大体时间：Up to day 29
Up to day 29

次要结果测量

结果测量
措施说明
大体时间
PK parameter: Area under the drug time curve from 0 to the last endpoint quantifiable concentration time point (AUCo- Last)
大体时间：Up to day 29
Up to day 29
PK parameter: Area under the drug time curve from 0 to 24 hours (AUCo-24)
大体时间：Up to day 29
Up to day 29
PK parameter: Area under the drug time curve from 0 to 168 hours (AUCo-168)
大体时间：Up to day 29
Up to day 29
PK parameter: D8 blood concentration (C168)
大体时间：Up to day 29
Up to day 29
PK parameter: peak time (Tmax)
大体时间：Up to day29
Up to day29
Safety indicators
大体时间：Up to day 29
The proportion of participants who experienced all adverse events (TEAEs), serious adverse events (SAEs), and adverse events of particular concern (AESIs) during the treatment period after a single subcutaneous administration of AHB-137 injection; And laboratory tests, 12 lead ECG, and changes in vital signs compared to baseline.
Up to day 29

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：Jing Zhang、Huashan Hospital
  • 首席研究员：Yuxian Huang、Huashan Hospital

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7月9日

初级完成 (估计的)

2028年5月15日

研究完成 (估计的)

2028年5月15日

研究注册日期

首次提交

2026年5月14日

首先提交符合 QC 标准的

2026年5月14日

首次发布 (实际的)

2026年5月22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27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-10-8010

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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