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This is a randomized, double-blind, placebo-controlled phase I clinical study with the primary objective of evaluating the safety and tolerability of SHR-2106 in healthy subjects after a single intravenous or subcutaneous administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: SHR-2106 injection or placebo single dose, iv | Experimental |
| |
| Part 2: SHR-2106 injection or placebo single dose, sc | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2106 injection or placebo | Drug | starting dose from 50 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the incidence and severity of adverse events in healthy subjects after single dose of SHR-2106 injection | About 6 months from the first medication to the evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the concentration of SHR-2106 in plasma | About 6 months after the first dose | |
| Evaluation of AUC0-t of SHR-2106 in plasma | About 6 months after the first dose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The third xiangya hospital of central south univercity | Changsha | Hunan | 410013 | China |
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| SHR-2106 injection or placebo | Drug | starting dose from 300 mg |
|
| Evaluation of AUC0-∞ of SHR-2106 in plasma |
| About 6 months after the first dose |
| Evaluation of Tmax of SHR-2106 in plasma | About 6 months after the first dose |
| Evaluation of Cmax of SHR-2106 in plasma | About 6 months after the first dose |
| Evaluation of t1/2 of SHR-2106 in plasma | About 6 months after the first dose |
| To assess incidence of ADA following a single intravenous of SHR-2106 in healthy subjects | About 6 months after the first dose |