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This study will be a single-center, randomized, parallel, open-label, single dosing bridging study in healthy subjects to evaluate bioequivalence of two formulations of SHR-1314. Subjects will be randomly assigned to the Vials group, the PFS group at a ratio of 1:1
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | SHR-1314 Vial |
|
| Group B | Active Comparator | SHR-1314 PFS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1314 | Drug | each group subjects will be given different formulations of SHR-1314 |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-last: Area under the serum concentration-time curve from time zero to the last measurable concentration | Compare the AUC0-last of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects | from Day1 to Day113 |
| Cmax: Observed maximum serum concentration | Compare the Cmax of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects | from Day1 to Day113 |
| AUC0-∞: Area under the serum concentration-time curve from time zero to infinity | Compare the AUC0-∞ of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects | from Day1 to Day113 |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax : Time at which observed maximum concentration occurs | Compare the Tmax of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects | from Day1 to Day113 |
| CL/F: Apparent clearance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Xu, Ph.D | Contact | 0186 021-68868370 | PRS_admin@hrglobe.cn | |
| Jianjun Zou, Ph.D | Contact | 0186 021-68868370 | PRS_admin@hrglobe.cn |
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Compare the CL/F of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects
| from Day1 to Day113 |
| t1/2: Terminal half-life | Compare the t1/2 of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects | from Day1 to Day113 |
| V/F:Apparent volume of distribution | Compare the V/F of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects | from Day1 to Day113 |
| Incidence and severity of adverse events (AEs). | Compare Incidence and severity of AE at 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects | from Day1 to Day113 |
| Anti-drug Antibodies (ADAs) | Incidence of development of Anti-drug Antibodies (ADAs) during the course of the study. | from Day1 to Day113 |