Phase 1 Clinical Study of JTE-451 ointment -Single and Multiple Dose Study
Phase 1
Completed
- Conditions
- Plaque psoriasis
- Registration Number
- JPRN-jRCT2080225252
- Lead Sponsor
- Japan Tobacco Inc.
- Brief Summary
Topical application of JTE-451 ointment in healthy volunteers and patients with plaque psoriasis was safe and well tolerated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
Cohort 1
-BMI of 18.5 to 25.0
Cohort 2,Cohort 3
-Subjects with a diagnosis of plaque psoriasis for at least 1 year
-Have a mPASI score of 4.5 or greater
Exclusion Criteria
Cohort 1
-Presence of skin conditions that would interfere with study evaluation
Cohort 2, Cohort 3
-Presence of pustular psoriasis, guttate psoriasis, erythrodermic psoriasis or medication-induced psoriasis
-Presence of infections
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method