Actively Recruiting
A Multi-center, Single-dose, Parallel-group, Open-label Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function
Led by Fujian Shengdi Pharmaceutical Co., Ltd. · Updated on 2026-06-01
24
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must understand and voluntarily sign informed consent before the trial.
- Female participants of childbearing potential must have a negative pregnancy test, not be lactating, and agree to use contraception until 2 months after the last dose.
- Male participants with partners of childbearing potential must agree to use contraception until 2 months after the last dose.
- Aged 18 to 65 years, male and female.
- Male participants must weigh at least 50 kg; female participants must weigh at least 45 kg.
- Body mass index (BMI) between 19.0 and 40.0 kg/m² inclusive.
You will not qualify if you...
- Participation in any other clinical trial within 3 months before dosing or during follow-up.
- History of severe drug allergy or drug anaphylaxis (except untreated seasonal allergies or positive skin tests only).
- Unable to abstain from smoking or alcohol during the trial; positive alcohol screening.
- Drug abuse or positive urine drug test.
- Blood loss or donation ≥400 mL within 3 months, or ≥200 mL within 1 month before dosing, or blood transfusion within 3 months.
- Surgery within 6 months before dosing or planned surgery during study.
- Malignant tumors or history of tumors within 5 years, except certain treated skin or cervical cancers.
- History of severe hypoglycemia.
- Significant gastric emptying issues, severe gastrointestinal diseases, or gastrointestinal surgery affecting motility.
- Any condition deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 29 days post-dose
Participants receive a single dose of HRS9531 Injection to evaluate its pharmacokinetics.
Approximately 6 visits from Day 1 to Day 29
Duration - 7 days after Day 29
Participants are monitored for safety and adverse events following the treatment period.
Visits up to Day 36 for safety assessments
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
Research Team
Y
Yanyan Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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