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This is a single-center, randomized, parallel-group, open-label clinical study designed to compare the bioavailability and safety of SHR-1703 Injection administered subcutaneously using a pre-filled safety syringe (PFS) or a pre-filled autoinjector (AI) in healthy participants.
A total of 84 healthy participants are planned to be enrolled and randomized in a 1:1 ratio to either the PFS group or the AI group. Participants in the PFS group will receive a single subcutaneous injection of SHR-1703 Injection using a pre-filled safety syringe, while participants in the AI group will receive a single subcutaneous injection of SHR-1703 Injection using a pre-filled autoinjector.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PFS Group (n=42) | Experimental |
| |
| AI Group (n=42) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1703 Injection | Drug | A single subcutaneous dose of SHR-1703 Injection administered via pre-filled safety syringe. |
|
| Measure | Description | Time Frame |
|---|---|---|
| peak concentration (Cmax) | Days 1-267 | |
| area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t), | Days 1-267 | |
| area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-∞) | Days 1-267 |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax, | Days 1-267 | |
| t1/2 | Days 1-267 | |
| CL/F, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenzheng Xiong | Contact | +86 13616029339 | wenzheng.xiong.wx10@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital , Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
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| SHR-1703 Injection | Drug | A single subcutaneous dose of SHR-1703 Injection administered via autoinjector. |
|
| Days 1-267 |
| Vz/F. | Days 1-267 |
| Safety and tolerability as assessed by the incidence and severity of AEs, | Days 1-267 |
| Immunogenicity of SHR-1703 as assessed by the presence and incidence of anti-drug antibodies (ADAs) and, if applicable, neutralizing antibodies (NAbs). | Days 1-267 |