Diabetes Mellitus, Weight Loss
Conditions
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.
Interventions
HRS9531 injection, specified dose on the specified day.
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study aims to compare the pharmacokinetics of HRS9531 Injection in participants with mild/moderate hepatic impairment and participants with normal hepatic function.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum concentration (Cmax) | Post-dose from Day 1 to Day 29. | HRS9531 key PK parameter. |
| The area under the concentration-time curve to the last measurable concentration (AUClast) | Post-dose from Day 1 to Day 29. | HRS9531 key PK parameter. |
| The area under the concentration-time curve extrapolated to infinity (AUCinf) | Post-dose from Day 1 to Day 29. | HRS9531 key PK parameter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to maximum concentration (Tmax) | Post-dose from Day 1 to Day 29. | HRS9531 other PK parameter. |
| Half-life (t1/2) | Post-dose from Day 1 to Day 29. | HRS9531 other PK parameter. |
| Apparent clearance (CL/F) | Post-dose from Day 1 to Day 29. | HRS9531 other PK parameter. |
| Apparent volume of distribution (Vz/F) | Post-dose from Day 1 to Day 29. | HRS9531 other PK parameter. |
| Adverse events (AEs) | Day 1 to Day 36. | Safety and tolerability. |
Countries
China
Contacts
CONTACTYanyan Zhang
Outcome results
None listed