Study of AHB-137 Injection Safety and Pharmacokinetics in Adults With and Without Mild to Moderate Liver Dysfunction

What this Trial Is About

Researchers are evaluating the pharmacokinetic properties and safety of a drug called AHB-137 injection in adults aged 18 to 65 years who have mild to moderate liver dysfunction as well as those with normal liver function. This study is designed as a Phase 1 clinical trial to better understand how the drug behaves in these different groups and to assess any potential safety concerns. It is sponsored by Ausper Biopharma Co., Ltd. and involves participants with chronic hepatitis B. Participants receive a single subcutaneous injection of AHB-137. The study includes two groups of participants with liver dysfunction classified as Child-Pugh A and Child-Pugh B, along with matched groups of participants with normal liver function. The groups are studied in parallel, and the trial compares how the drug is processed in their bodies. The dosing involves only one administration, and the study duration extends up to 29 days for monitoring. During the study, participants undergo various assessments to measure pharmacokinetic parameters, including peak concentration and drug exposure over time area under the curve up to day 29. Safety indicators are also monitored throughout this period. Participants may have physical exams, laboratory tests, and other procedures to ensure safety and collect data on the drugs behavior. The total participation time lasts up to 29 days following the injection.

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.