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NCT Number: NCT07540754

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HRS9531 injection

Drug

HRS9531 injection, specified dose on the specified day.

Primary outcomes

  1. Maximum concentration (Cmax)

    Time frame: Post-dose from Day 1 to Day 29.

    HRS9531 key PK parameter.

  2. The area under the concentration-time curve to the last measurable concentration (AUClast)

    Time frame: Post-dose from Day 1 to Day 29.

    HRS9531 key PK parameter.

  3. The area under the concentration-time curve extrapolated to infinity (AUCinf)

    Time frame: Post-dose from Day 1 to Day 29.

    HRS9531 key PK parameter.

Secondary outcomes

  1. Time to maximum concentration (Tmax)

    Time frame: Post-dose from Day 1 to Day 29.

    HRS9531 other PK parameter.

  2. Half-life (t1/2)

    Time frame: Post-dose from Day 1 to Day 29.

    HRS9531 other PK parameter.

  3. Apparent clearance (CL/F)

    Time frame: Post-dose from Day 1 to Day 29.

    HRS9531 other PK parameter.

  4. Apparent volume of distribution (Vz/F)

    Time frame: Post-dose from Day 1 to Day 29.

    HRS9531 other PK parameter.

  5. Adverse events (AEs)

    Time frame: Day 1 to Day 36.

    Safety and tolerability measure.

Study contacts

Contact information is provided by the study sponsor or research team.

Yanyan Zhang

CONTACT

[email protected]

+86-0518-81220121

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 20, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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