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The study is being conducted to evaluate the safety and pharmacokinetic characteristics of SHR8554 injection in subjects with renal insufficiency and healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal renal function group | Experimental |
| |
| Severe renal dysfunction group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR8554 Injection | Drug | SHR8554 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration of SHR8554 (Cmax). | 0 hour to 48 hours after administration. | |
| Area under the serum concentration time curve (AUC) of SHR8554. | 0 hour to 48 hours after administration. | |
| Half-life (t1/2) of SHR8554. | 0 hour to 48 hours after administration. | |
| Clearance (CL) of SHR8554. | 0 hour to 48 hours after administration. | |
| Volume of distribution (Vz) of SHR8554. | 0 hour to 48 hours after administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative excretion (Ae) of SHR8554. | 0 hour to 48 hours after administration. | |
| Urinary excretion fraction (fe) of SHR8554. | 0 hour to 48 hours after administration. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266003 | China |
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| Renal clearance (CLr) of SHR8554. |
| 0 hour to 48 hours after administration. |
| Plasma protein binding rate of SHR8554 in patients with renal insufficiency. | 0 hour to 48 hours after administration. |