NCT07600788RecruitingPhase 1
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.
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 14 May 2026
- Start date
- 9 Jul 2026
- Primary completion date
- 15 May 2028
- Lead sponsor
- Ausper Biopharma Co., Ltd.
- Diseases
- Hepatitis B
- NCT number
- NCT07600788
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 32
- From 9 Jul 2026 to the primary completion date, 15 May 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Screening for participants who have undergone significant trauma or surgery within the previous 3 months, as well as those who plan to undergo surgery;
- 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;
- Positive results in urine drug screening and alcohol breath screening tests during screening;
- 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;
- Participants with normal liver function who have used traditional Chinese medicine or other systemic medications with potential liver toxicity 14 days before administration;
Other illness
- Diagnosed or suspected liver cancer participants who have undergone liver transplantation;
- 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;
- Allergic or allergic constitution to AHB-137;
- HIV, Syphilis positive ;
- 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;
- Participants with normal liver function who have a history of chronic liver disease or known liver or biliary abnormalities;
Lab values
- History of vasculitis or presence of signs and symptoms of potential vasculitis or laboratory tests;
- 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;
- The laboratory test results do not meet the requirements of the protocol;
Other
- Participants with thyroid dysfunction who are not suitable for inclusion in the study;
- Those who are participating in another clinical trial and have not been eluted as required;
- Those who drink excessively and consume prohibited foods and beverages before administration;
- Long term regular vigorous exercise or intense exercise within 48 hours before screening;
- Participants with normal liver function and abnormal QTcF values.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Chengdu | China | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Chongqing | China | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Hangzhou | China | Not yet recruiting |
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| - Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.