A Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate… (NCT07540754) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function
China24 participantsStarted 2026-05
Plain-language summary
This is a Phase I clinical study to compare the pharmacokinetics (PK) of HRS9531 Injection in participants with mild/moderate hepatic impairment and participants with normal hepatic function, and to evaluate the safety of HRS9531 Injection in these participants.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Participants must fully understand and voluntarily sign a written informed consent form before the trial, demonstrating comprehension of the trial content, procedures, and potential adverse reactions; they must also be willing and able to comply with the protocol requirements to complete the study.
✓. Female participants of childbearing potential must have a negative baseline serum pregnancy test, must not be lactating, and must agree to use contraceptive measures and refrain from egg donation from the time of signing the informed consent form until 2 months after the last dose of the study drug; male participants with partners of childbearing potential must agree to use contraceptive measures and refrain from sperm donation from the time of signing the informed consent form until 2 months after the last dose of the study drug.
✓. Aged 18 to 65 years (inclusive), both male and female.
✓. Male participants weigh no less than 50 kg, and female participants weigh no less than 45 kg. Body mass index (BMI) is within the range of 19.0 to 40.0 kg/m² (inclusive).
Exclusion criteria
✕. Participation in any clinical trial of a drug or medical device within 3 months prior to dosing, or currently within the follow-up period of a clinical study or within 5 half-lives of the investigational drug (whichever is longer).
✕. Allergic constitution, including a history of severe drug allergy or drug anaphylaxis, excluding untreated asymptomatic seasonal allergies or individuals with positive skin tests only.
✕. Smokers and drinkers who are unable to abstain during the trial period; positive alcohol screening test.
✕
What they're measuring
1
Maximum concentration (Cmax)
Timeframe: Post-dose from Day 1 to Day 29.
2
The area under the concentration-time curve to the last measurable concentration (AUClast)
Timeframe: Post-dose from Day 1 to Day 29.
3
The area under the concentration-time curve extrapolated to infinity (AUCinf)
. Drug abusers or those with a positive urine drug screening test.
✕. Blood loss or blood donation ≥400 mL within 3 months prior to dosing, or blood loss or blood donation ≥ 200 mL within 1 month prior to dosing, or receipt of a blood transfusion within 3 months prior to dosing.
✕. Undergone any surgery within 6 months prior to dosing, or planned to undergo surgical procedures during the study period.
✕. Suffering from malignant tumors, or having a history of malignant tumors within 5 years prior to screening (excluding non-melanoma skin cancer that has been treated with no signs of recurrence, and resected cervical intraepithelial neoplasia).