Phase 1 Clinical Study of JTE-052A - Single and Multiple Dose study
Phase 1
Completed
- Conditions
- healthy volunteers and skin diseases
- Registration Number
- JPRN-jRCT2080222444
- Lead Sponsor
- Japan Tobacco Inc.
- Brief Summary
There were no safety concerns of JTE-052 when JTE-052 ointment was applied to healthy Japanese adult male volunteers and patients with atopic dermatitis. There was extremely low systemic exposure of JTE-052.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
Healthy volunteers
-Patients with skin diseases
Exclusion Criteria
Part1
- Those who have a history of contact dermatitis caused by dermatological drugs, tape, adhesive plaster, compression, etc. or mechanical urticaria
Part2, Part3
- Those who have a history of contact dermatitis caused by dermatological drugs, tape, adhesive plaster, compression, etc. or mechanical urticaria
- Those who have changed the dosage regimen of topical steroids or tacrolimus hydrate ointment within 7 days before the day of spitalization
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method