A Single-center, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Assess the Safety and Pharmacokinetics of OPA-15406 Ointment in Healthy Adult Male Subjects (Phase 1 Trial)
Phase 1
- Conditions
- Atopic Dermatitis
- Registration Number
- JPRN-jRCT2080222706
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 32
Inclusion Criteria
BMI {Body weight (kg) / [Height (m)]2}: at least 18.5 and less than 25.0
-Judged by the investigator or subinvestigator to be healthy based on test results at screening and prior to administration on Day 1 of the treatment period
Exclusion Criteria
-Findings (sunburn, abrasions, tattoos, etc) on the back that affect the evaluation of the safety of the skin.
-Judged by the investigator or subinvestigator as inappropriate to participate in this trial for any other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety (especially skin findings)<br>Adeverse Events
- Secondary Outcome Measures
Name Time Method Pharmacokinetics<br>Cmax and AUC