AHB-137 injection in adults with chronic hepatitis B and different levels of liver function
Studies how the body handles and tolerates AHB-137 in people with liver dysfunction.
Plain-language title generated from the registry record
Registry title: 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.
Key facts
- Where
- Chengdu, Chongqing, Hangzhou, Shanghai, and Zhengzhou, ChinaSee the 5 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07600788, who can take part
Where in China
- ChengduChengdu, ChinaNot yet recruiting
- ChongqingChongqing, ChinaNot yet recruiting
- HangzhouHangzhou, ChinaNot yet recruiting
- Huashan Hospital, Fudan UniversityShanghai, ChinaTaking people
- ZhengzhouZhengzhou, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ausper Biopharma Co., Ltd.
- Trial code
- NCT07600788
- Record updated
- 29 July 2026
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: 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: 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; 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; 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; 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.