AHB-137 injection pharmacokinetics and safety in people with mild to moderate liver dysfunction and normal liver function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 interventional study will evaluate the pharmacokinetic characteristics and safety of AHB-137 injection in adults aged 18 to 65 with chronic hepatitis B, comparing those with liver function impairment to those with normal liver function. Participants with liver impairment must meet specified liver function criteria, while those with normal liver function are matched by age, weight, and sex and undergo similar assessments. The trial will assess how the drug is absorbed, distributed, metabolized, and excreted, and monitor for adverse events and laboratory changes. Exclusion criteria include liver cancer, prior liver transplantation, signs of vasculitis, and unstable cardiovascular or metabolic conditions. Lead sponsor is Ausper Biopharma Co., with collaboration from accredited sites in Chongqing, Zhengzhou, and Shanghai.

Why it matters

Who can join: the full rules

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.

Where it's running

• Huashan Hospital Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• AusperBio Investigational Site
  Chongqing, Chongqing Municipality, China Not yet recruiting
• AusperBio Investigational Site
  Zhengzhou, Henan, China Not yet recruiting
• AusperBio Investigational Site
  Chengdu, Sichuan, China Not yet recruiting
• AusperBio Investigational Site
  Hangzhou, Zhejiang, China Not yet recruiting

Study contacts

• Principal investigator: Jing Zhang — Huashan Hospital
• Study coordinator: Lu
• Email: clinicaltrial@ausperbio.com
• Phone: 0571-86959519

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.