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This study is a single center, randomized, double-blind, Vehicle controlled,, single and multiple dose clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VC005 Low Dose groups | Experimental |
| |
| VC005 median-A Dose groups | Experimental |
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| VC005 median-B Dose groups | Experimental |
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| VC005 high Dose groups | Experimental |
| |
| VC005 Placebo groups | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VC005 | Drug | VC005 group with Local topical application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Day2,Day 4,Day17,Day31 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in EASI(Eczema area and severity index) from baseline | Week 2,Week 4 |
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Inclusion Criteria:
healthy subject's study:
patient's study:
When informed consent is given, the age range is between 18 and 75 years (including the boundary value), regardless of gender;
Body mass index (BMI) between 18 and 26kg/m2 (including critical values), with male weight ≥ 50kg and female weight ≥ 45kg;
Before administration, the diagnosis of mild to moderate atopic dermatitis should be met:
Overall Investigator Assessment (IGA) score of 2 to 3 points; Atopic dermatitis: total area of skin lesions 3% ≤ body surface area≤ 20%
Voluntarily sign an informed consent form (with a date), indicating that the subject has been informed of all relevant parts of the study;
All women and men with the possibility of childbirth must be willing to use at least one efficient method of contraception from the signing of the informed consent form until 3 months after the last administration of the study drug, as detailed in Appendix 5;
Subjects who are willing and able to comply with planned visits and treatment plans, laboratory tests, and other research procedures
Exclusion Criteria:
healthy subject's study:
patient's study:
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| Name | Affiliation | Role |
|---|---|---|
| Qianjin Lu | Chinese Academy of Medical Sciences Hospital of Skin Disease | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences Hospital of Skin Disease | Nanjing | Jiangsu | China |
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| VC005 Placebo | Drug | VC005 Placebo group with Local topical application |
|
| 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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