NCT07540754 A Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function
| NCT ID | NCT07540754 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Fujian Shengdi Pharmaceutical Co., Ltd. |
| Condition | Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-05-26 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2026-05-26 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07540754 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07540754 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07540754 currently recruiting?
Yes, NCT07540754 is actively recruiting participants. Contact the research team at yanyan.zhang@hengrui.com for enrollment information.
Where is the NCT07540754 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT07540754 clinical trial?
NCT07540754 is sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.. The trial plans to enroll 24 participants.
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