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The purpose of this study is to assess safety, PK and immunogenicity profile of a single dose of SHR-1139 in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1139 dose level 1 | Experimental | Single dose of SHR-1139 given subcutaneously (dose level 1) |
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| SHR-1139 dose level 2 | Experimental | Single dose of SHR-1139 given subcutaneously (dose level 2) |
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| SHR-1139 dose level 3 | Experimental | Single dose of SHR-1139 given intravenously (dose level 3) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1139 Injection | Drug | Single dose of SHR-1139 given subcutaneously (dose level 1 ) |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK profile of SHR-1139 after a single administration | Pharmacokinetics- Area under the concentration-time curve from time 0 to last time point after SHR-1139 administration (AUC0-last) | Start of Treatment to end of study (Day 253) |
| PK profile of SHR-1139 after a single administration | Pharmacokinetics- Area under the concentration-time curve (AUC0-inf) | From time 0 to infinity after SHR-1139 administration (Day 253) |
| PK profile of SHR-1139 after a single administration: | Pharmacokinetics- Time to Cmax of SHR-1139 (Tmax ) | Start of Treatment to end of study (Day 253) |
| PK profile of SHR-1139 after a single administration | Pharmacokinetics-Terminal elimination half-life of SHR-1139 (t1/2) | Start of Treatment to end of study (Day 253) |
| Immunogenicity profile of SHR-1139 after a single dose administration | The number of participants with anti-drug antibody (ADA) | Day 253 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events | Number of participants with Adverse events and Serious adverse events | Day 295 |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear | Perth | Western Australia | Australia |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| SHR-1139 Injection | Drug | Single dose of SHR-1139 given subcutaneously (dose level 2 ) |
|
| SHR-1139 Injection | Drug | Single dose of SHR-1139 given intravenously (dose level 3) |
|