A Phase 1 Trial of OPA-15406 Ointment in Healthy Adult Male Subjects

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)

To assess the safety (especially skin findings) and pharmacokinetics by applying 0.3%, 1%, or 3% formulation of 5g OPA-15406 ointment to a 1000 cm2 area as a single-dose and as a multiple-dose twice daily for 2 weeks in Japanese healthy adult male subjects.

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