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This study mainly evaluated the safety and tolerability, as well as the pharmacokinetic characteristics, of the injectable drug HRS-2183 after single and multiple administrations in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A:HRS-2183 | Experimental |
| |
| Treatment group B:placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-2183 | Drug | HRS-2183 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of any adverse events | Evaluation was performed up to the seventh day / the 16th day |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax (Pharmacokinetic Parameters after a Single Dose) | Evaluation was performed up to the third day | |
| Cmax(Pharmacokinetic Parameters after a Single Dose) | Evaluation was performed up to the third day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuanyuan Huang | Contact | +0518-82342973 | yuanyuan.huang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250100 | China |
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| Drug |
placebo |
|
| AUC0-t(Pharmacokinetic Parameters after a Single Dose) | Evaluation was performed up to the third day |
| AUC0-∞(Pharmacokinetic Parameters after a Single Dose) | Evaluation was performed up to the third day |
| t1/2(Pharmacokinetic Parameters after a Single Dose) | Evaluation was performed up to the third day |
| CLz(Pharmacokinetic Parameters after a Single Dose) | Evaluation was performed up to the third day |
| Vz(Pharmacokinetic Parameters after a Single Dose) | Evaluation was performed up to the third day |
| Ae0-t(Pharmacokinetic Parameters after a Single Dose) | Evaluation was performed up to the third day |
| Fe0-t(Pharmacokinetic Parameters after a Single Dose) | Evaluation was performed up to the third day |
| CLr(Pharmacokinetic Parameters after a Single Dose) | Evaluation was performed up to the third day |
| Tmax(Pharmacokinetic Parameters after Multiple Doses) | Evaluation was performed up to the 12th day |
| Cmin,ss(Pharmacokinetic Parameters after Multiple Doses) | Evaluation was performed up to the 12th day |
| Cmax,ss(Pharmacokinetic Parameters after Multiple Doses) | Evaluation was performed up to the 12th day |
| Cav(Pharmacokinetic Parameters after Multiple Doses) | Evaluation was performed up to the 12th day |
| AUC0-t,ss(Pharmacokinetic Parameters after Multiple Doses) | Evaluation was performed up to the 12th day |
| AUC0-τ,ss(Pharmacokinetic Parameters after Multiple Doses) | Evaluation was performed up to the 12th day |
| AUC0-∞,ss(Pharmacokinetic Parameters after Multiple Doses) | Evaluation was performed up to the 12th day |
| t1/2(Pharmacokinetic Parameters after Multiple Doses) | Evaluation was performed up to the 12th day |
| CLss(Pharmacokinetic Parameters after Multiple Doses) | Evaluation was performed up to the 12th day |
| Vss(Pharmacokinetic Parameters after Multiple Doses) | Evaluation was performed up to the 12th day |
| Rac(Pharmacokinetic Parameters after Multiple Doses) | Evaluation was performed up to the 12th day |
| DF(Pharmacokinetic Parameters after Multiple Doses) | Evaluation was performed up to the 12th day |