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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)

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)

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222706
Enrollment
32
Registered
2015-01-06
Start date
2015-01-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Interventions

investigational material(s) Generic name etc : OPA-15406 Ointment (0.3%, 1% and 3%) INN of investigational material : Therapeutic category code : 269 Other agents for epidermis Dosage and Administra

Sponsors

Otsuka Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Safety (especially skin findings) Adeverse Events—

Secondary

MeasureTime frame
Pharmacokinetics Cmax and AUC—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026