A First-in-Human Study of CEE321 in Adult Subjects
Phase 1
Completed
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: CEE321
- Registration Number
- NCT04612062
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
Open label, non-randomized, uncontrolled, First-in-Human Phase 1 Study in Healthy Subjects and Subjects with Atopic Dermatitis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Healthy Subjects (Part A) CEE321 CEE321 0.2% (3 mg/cm2) topical cream b.i.d. Atopic Dermatitis (Part B) CEE321 CEE321 0.2% (3 mg/cm2) topical cream b.i.d.
- Primary Outcome Measures
Name Time Method Number of subjects with adverse events adverse events recorded during study
- Secondary Outcome Measures
Name Time Method Plasma trough concentration of CEE321 day 15
Trial Locations
- Locations (1)
Novartis Investigative Site
🇯🇵Hachioji, Tokyo, Japan