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This is a randomized, double-blind, single/multiple dose escalation, placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in healthy subjects and patients with moderate to severe atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
| |
| Group 2 | Experimental |
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| Group 3 | Experimental |
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| Group 4 | Experimental |
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| Group 5 | Experimental |
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| Group 6 | Experimental |
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| Group 7 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM512 | Biological | CM512 injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incidence of adverse events. | Up to 141 days or up to 169 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jingyi Li | West China Hospital | Principal Investigator |
| Ping Feng | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42292382 | Derived | Cheng Y, Liu Q, Li M, Xie Y, Men Y, He M, Wang H, Feng X, Zeng M, Zhang L, Chen B, Li J, Feng P. First-in-human, phase 1 study of CM512, a TSLP/IL-13 bispecific antibody, in healthy volunteers: safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity. Front Immunol. 2026 May 28;17:1811041. doi: 10.3389/fimmu.2026.1811041. eCollection 2026. |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Placebo | Drug | Placebo |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |