Actively Recruiting
Phase 1 Study to Compare How HRS9531 Injection Acts in Adults With Mild, Moderate, or Normal Liver Function
Led by Fujian Shengdi Pharmaceutical Co., Ltd. · Updated on 2026-06-01
24
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are conducting a Phase I clinical study to compare how the drug HRS9531 Injection behaves in the body pharmacokinetics among participants with mild or moderate liver impairment and those with normal liver function. The study also aims to assess the safety of the HRS9531 Injection in these groups. Participants include adults aged 18 to 65 years with varying liver functions. The study involves three groups participants with mild hepatic impairment, moderate hepatic impairment, and normal hepatic function. Each participant receives a single specified dose of HRS9531 Injection. The study is open-label and non-randomized, meaning both participants and researchers know the treatment given, and participants are assigned based on their liver function status. Participants will be monitored from Day 1 to Day 29 for drug concentration levels, including maximum concentration and area under the curve measures. Safety and adverse events will be recorded through Day 36. The study includes assessments of drug clearance, distribution, half-life, and time to maximum concentration. Participants must comply with study procedures and attend all scheduled visits throughout the trial duration.
CONDITIONS
Brief Title
A Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function
Research Team
Y
Yanyan Zhang
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