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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
GroupInterventionDescription
Healthy Subjects (Part A)CEE321CEE321 0.2% (3 mg/cm2) topical cream b.i.d.
Atopic Dermatitis (Part B)CEE321CEE321 0.2% (3 mg/cm2) topical cream b.i.d.
Primary Outcome Measures
NameTimeMethod
Number of subjects with adverse eventsadverse events recorded during study
Secondary Outcome Measures
NameTimeMethod
Plasma trough concentration of CEE321day 15

Trial Locations

Locations (1)

Novartis Investigative Site

🇯🇵

Hachioji, Tokyo, Japan

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