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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group of Participants with mild hepatic impairment | Experimental | Participants with mild hepatic impairment. |
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| Group of Participants with moderate hepatic impairment | Experimental | Participants with moderate hepatic impairment. |
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| Group of Participants with normal hepatic function | Experimental | Participants with normal hepatic function. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS9531 Injection | Drug | HRS9531 injection, specified dose on the specified day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) | 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) | HRS9531 key PK parameter. | Post-dose from Day 1 to Day 29. |
| The area under the concentration-time curve extrapolated to infinity (AUCinf) | HRS9531 key PK parameter. | Post-dose from Day 1 to Day 29. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum concentration (Tmax) | HRS9531 other PK parameter. | Post-dose from Day 1 to Day 29. |
| Half-life (t1/2) | HRS9531 other PK parameter. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanyan Zhang | Contact | +86-0518-81220121 | yanyan.zhang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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This study aims to compare the pharmacokinetics of HRS9531 Injection in participants with mild/moderate hepatic impairment and participants with normal hepatic function.
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| Post-dose from Day 1 to Day 29. |
| Apparent clearance (CL/F) | HRS9531 other PK parameter. | Post-dose from Day 1 to Day 29. |
| Apparent volume of distribution (Vz/F) | HRS9531 other PK parameter. | Post-dose from Day 1 to Day 29. |
| Adverse events (AEs) | Safety and tolerability measure. | Day 1 to Day 36. |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |