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The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics and immunogenicity of a single dose of SHR-2173 by subcutaneous injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Experimental |
| |
| Treatment group C | Experimental |
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| Treatment group D | Experimental |
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| Treatment group E | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2173 | Drug | SHR-2173 injection dose 1; |
| |
| SHR-2173 ;Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent Adverse Events (TEAE) | Day1~Day71 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Day1~Day71 | |
| AUC0-t | Day1~Day71 | |
| AUC0-∞ |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haikou People's Hospital | Haikou | Hainan | 570208 | China |
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| Drug |
SHR-2173 injection dose 2 ;Pacebo dose 2 |
|
| SHR-2173 ;Placebo | Drug | SHR-2173 injection dose 3 ;Pacebo dose 3 |
|
| SHR-2173 ;Placebo | Drug | SHR-2173 injection dose 4 ;Pacebo dose 4 |
|
| SHR-2173 ;Placebo | Drug | SHR-2173 injection dose 5 ;Pacebo dose 5 |
|
| Day1~Day71 |
| Tmax, | Day1~Day71 |
| t1/2, | Day1~Day71 |
| CLz/F, | Day1~Day71 |
| Vz/F, | Day1~Day71 |
| Immunogenicity :Anti- SHR -2173 antibody (ADA) | Day1~Day71 |