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

May 28, 2026 updated by: Fujian Shengdi Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Principal Investigator:
          • Xin Tian
        • Contact:
        • Contact:
          • Xin Tian
          • Phone Number: +86-13903830361
          • Email: tianx@zzu.cn
        • Principal Investigator:
          • Zujiang Yu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Aged 18 to 65 years (inclusive), both male and female.
  4. 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:

  1. 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).
  2. Allergic constitution, including a history of severe drug allergy or drug anaphylaxis, excluding untreated asymptomatic seasonal allergies or individuals with positive skin tests only.
  3. Smokers and drinkers who are unable to abstain during the trial period; positive alcohol screening test.
  4. Drug abusers or those with a positive urine drug screening test.
  5. 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.
  6. Undergone any surgery within 6 months prior to dosing, or planned to undergo surgical procedures during the study period.
  7. 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).
  8. History of severe hypoglycemia.
  9. 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.).
  10. Anyone with factors making them unsuitable to participate in this trial evaluated by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group of Participants with mild hepatic impairment
Participants with mild hepatic impairment.
Drug: HRS9531 Injection
HRS9531 injection, specified dose on the specified day.
Experimental: Group of Participants with moderate hepatic impairment
Participants with moderate hepatic impairment.
Drug: HRS9531 Injection
HRS9531 injection, specified dose on the specified day.
Experimental: Group of Participants with normal hepatic function
Participants with normal hepatic function.
Drug: HRS9531 Injection
HRS9531 injection, specified dose on the specified day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum concentration (Cmax)
Time Frame: Post-dose from Day 1 to Day 29.
HRS9531 key PK parameter.
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.
HRS9531 key PK parameter.
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.
HRS9531 key PK parameter.
Post-dose from Day 1 to Day 29.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to maximum concentration (Tmax)
Time Frame: Post-dose from Day 1 to Day 29.
HRS9531 other PK parameter.
Post-dose from Day 1 to Day 29.
Half-life (t1/2)
Time Frame: Post-dose from Day 1 to Day 29.
HRS9531 other PK parameter.
Post-dose from Day 1 to Day 29.
Apparent clearance (CL/F)
Time Frame: Post-dose from Day 1 to Day 29.
HRS9531 other PK parameter.
Post-dose from Day 1 to Day 29.
Apparent volume of distribution (Vz/F)
Time Frame: Post-dose from Day 1 to Day 29.
HRS9531 other PK parameter.
Post-dose from Day 1 to Day 29.
Adverse events (AEs)
Time Frame: Day 1 to Day 36.
Safety and tolerability measure.
Day 1 to Day 36.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS9531-110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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