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To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of HRS-9231 injection in a single dose in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 8 healthy subjects were to be included |
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| Group 2 | Experimental | 8 healthy subjects were to be included |
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| Group 3 | Experimental | 8 healthy subjects were to be included |
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| Group 4 | Experimental | 8 healthy subjects were to be included |
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| Group 5 | Experimental | 8 healthy subjects were to be included |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-9231 | Drug | HRS-9231 was administered intravenously; |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, serious adverse events | From ICF signing date to Day10 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax:maximum concentration measured. Blood samples were taken to assess HRS-9231 concentration | From baseline (1 hour before injection) to 12 hours post-injection | |
| t1/2 = terminal elimination half-life of the compound | From baseline (1 hour before injection) to 12 hours post-injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
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| Placebo | Drug | Placebo was administered intravenously. |
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| Cl = total clearance | From baseline (1 hour before injection) to 12 hours post-injection |