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.

Overview

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.

Interventions

• Drug AHB-137 injection
  Single use subcutaneous injection

Primary outcome measures

• Key PK parameters of AHB-137 injection after single subcutaneous administration: peak concentration (Cmax) [Time frame: 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) [Time frame: Up to day 29]

Secondary outcome measures (6)

• PK parameter: Area under the drug time curve from 0 to the last endpoint quantifiable concentration time point (AUCo- Last) [Time frame: Up to day 29]
• PK parameter: Area under the drug time curve from 0 to 24 hours (AUCo-24) [Time frame: Up to day 29]
• PK parameter: Area under the drug time curve from 0 to 168 hours (AUCo-168) [Time frame: Up to day 29]
• PK parameter: D8 blood concentration (C168) [Time frame: Up to day 29]
• PK parameter: peak time (Tmax) [Time frame: Up to day29]
• Safety indicators [Time frame: Up to day 29]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 5 centers

• AusperBio Investigational Site — Chongqing
• AusperBio Investigational Site — Zhengzhou
• Huashan Hospital Fudan University — Shanghai
• AusperBio Investigational Site — Chengdu
• AusperBio Investigational Site — Hangzhou

Identifiers

NCT: NCT07600788 · AB-10-8010

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗