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This trial was designed to evaluate the safety of SHR-1819 in children and adolescents with moderate-to-severe atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1819 injection | Experimental | Dose 1, dose 2 and dose 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1819 injection | Drug | SHR-1819 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Up to 14 weeks. | |
| Heart rate | Up to 14 weeks. | |
| PR interval | Up to 14 weeks. | |
| QT interval | Up to 14 weeks. | |
| QRS duration | Up to 14 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The concentration of SHR-1819 in serum | From the beginning of administration to the 14th week. | |
| Changes in the level of TARC/CCL17 in the serum | Changes in the level of biomarkers in serum. | From the beginning of administration to the 14th week. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital, Capital Medical University | Beijing | Beijing Municipality | 100045 | China | ||
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| Evaluate the incidence and timing of ADA positivity for SHR-1819 | Changes in the level of immunogenicity in the body. | From the beginning of administration to the 14th week. |
| The First Affiliated Hospital of China Medical University |
| Shenyang |
| Liaoning |
| 110002 |
| China |