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To investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple subcutaneous injections of SHR-2173 in patients with systemic lupus erythematosus (SLE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: | Experimental | SHR-2173 injection dose 1 |
|
| Treatment group B: | Experimental | SHR-2173 injection dose 2 |
|
| Treatment group C: | Experimental | SHR-2173 injection dose 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2173 | Drug | SHR-2173 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Week 0~16 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax, | Week 0~16 | |
| AUC0-t, | Week 0~16 | |
| Anti- SHR -2173 antibody (ADA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital affiliated to Shanghai Jiaotong | Shanghai | Shanghai Municipality | 200000 | China |
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| Week 0~16 |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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