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This study is an Ic/II phase clinical trial conducted in Chinese subjects with moderate to severe atopic dermatitis. The phase Ic study is a randomized, open label, parallel group design, mainly evaluating the safety and tolerability of LT-002-158 tablets in subjects with moderate to severe atopic dermatitis. The phase II study is a randomized, double-blind, placebo-controlled, parallel group design, with a single arm design for extended treatment, mainly exploring the efficacy of LT-002-158 tablets in the treatment of moderate to severe atopic dermatitis subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LT-002-158 tablets low-dose group | Experimental |
| |
| LT-002-158 tablets high-dose group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LT-002-158 tablets | Drug | The subjects will orally administered LT-002-158 tablets once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment emergent Adverse Events | up to 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve plasma concentration from time zero to last measurable concentration [AUC(0-last)] | up to 42 days | |
| Maximum observed plasma concentration at steady state (Cmax,ss) | up to 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Xu | Contact | 021-50561622 | jxu@leadingtac.com |
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| Minimum observed plasma concentration at stead state (Cmin,ss) | up to 42 days |
| 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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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