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This is a single center, randomized, double-blind, placebo-controlled, dose escalation study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 75 mg | Experimental | CM310 Recombinant Humanized Monoclonal Antibody Injection |
|
| Group 150 mg | Experimental | CM310 Recombinant Humanized Monoclonal Antibody Injection |
|
| Group 300 mg | Experimental | CM310 Recombinant Humanized Monoclonal Antibody Injection |
|
| Group 600 mg | Experimental | CM310 Recombinant Humanized Monoclonal Antibody Injection |
|
| Placebo | Placebo Comparator | Placebo, Subcutaneous |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM310 | Biological | CM310 injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event | Incidence of adverse events. | up to Week 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PKUCare Luzhong Hospital | Zibo | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38833140 | Derived | Zhang L, Zhang W, Xu Y, Dong L, Sun Y, Jia Y, Li Z, Chen B, Hou J, Zhang J. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Stapokibart in Healthy Volunteers and Adult Subjects with Atopic Dermatitis. Adv Ther. 2024 Jul;41(7):2953-2965. doi: 10.1007/s12325-024-02887-w. Epub 2024 Jun 4. |
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| Placebo | Drug | subcutaneous injection |
|