A Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function

Official title

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

Overview

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.

Interventions

• Drug HRS9531 Injection
  HRS9531 injection, specified dose on the specified day.

Primary outcome measures

• Maximum concentration (Cmax) [Time frame: Post-dose from Day 1 to Day 29.]
• The area under the concentration-time curve to the last measurable concentration (AUClast) [Time frame: Post-dose from Day 1 to Day 29.]
• The area under the concentration-time curve extrapolated to infinity (AUCinf) [Time frame: Post-dose from Day 1 to Day 29.]

Secondary outcome measures (5)

• Time to maximum concentration (Tmax) [Time frame: Post-dose from Day 1 to Day 29.]
• Half-life (t1/2) [Time frame: Post-dose from Day 1 to Day 29.]
• Apparent clearance (CL/F) [Time frame: Post-dose from Day 1 to Day 29.]
• Apparent volume of distribution (Vz/F) [Time frame: Post-dose from Day 1 to Day 29.]
• Adverse events (AEs) [Time frame: Day 1 to Day 36.]

Eligibility criteria

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.
• 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).
• History of severe hypoglycemia.
• Previous significant gastric emptying abnormalities or factors affecting gastric emptying (e.g., history of gastric bypass surgery, pyloric stenosis), or severe gastrointestinal diseases (e.g., active peptic ulcer, inflammatory bowel disease, etc.), or have undergone gastrointestinal surgery (excluding surgeries with no significant impact on gastrointestinal motility, such as removal of gastrointestinal polyps, appendectomy, hemorrhoidectomy, etc.).
• Anyone with factors making them unsuitable to participate in this trial evaluated by the investigator.

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 · 1 center

• The First Affiliated Hospital of Zhengzhou University — Zhengzhou

Identifiers

NCT: NCT07540754 · HRS9531-110

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗