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This is a clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic and immunogenicity of SHR-1139 injection in healthy subjects who receive a single subcutaneous injection or intravenous infusion of SHR-1139 injection, and in patients with moderate - to - severe plaque psoriasis who receive multiple subcutaneous injections of SHR-1139 injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1139 Injections Group | Experimental |
| |
| SHR-1139 Injections Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1139 Injections | Drug | SHR-1139 injections. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | About 365 days for moderate-to-severe plaque psoriasis subjects | |
| Adverse events (AEs) | About 295 days for healthy subjects. | |
| Serious adverse events (SAEs) | About 295 days for healthy subjects. | |
| Serious adverse events (SAEs) | About 365 days for moderate-to-severe plaque psoriasis subjects. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration of SHR-1139 | About 253 days for healthy subjects. | |
| Serum concentration of SHR-1139 | About 365 days for moderate-to-severe plaque psoriasis subjects. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200031 | China |
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| SHR-1139 Injections Placebo |
| Drug |
SHR-1139 injections placebo |
|