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This study will be a single-center, randomized, parallel, open-label, single dosing bridging study in healthy subjects to evaluate the pharmacokinetics and safety of two formulations of SHR-1314.
This study will be a single-center, randomized, parallel, open-label, single dosing (SHR-1314 240mg) bridging study in healthy subjects to evaluate the pharmacokinetics and safety of two formulations of SHR-1314.
The study will consist of a 14-days screening period (-14~-1 days); an observation period (1-3 days) and the follow-up period (4-113 days); Subjects will be randomly assigned to three group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1314 A | Experimental | single dosing SHR-1314 A |
|
| SHR-1314 B | Experimental | single dosing SHR-1314 B |
|
| SHR-1314 C | Experimental | single dosing SHR-1314 C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1314 | Drug | single dosing |
|
| 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 | xuqian@hrglobe.cn | |
| Jianwen Chen, Ph.D. | Contact | 0186 021-68868370 |
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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 |
| 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 |