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

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions
Atopic Dermatitis
Interventions
DRUG

0.3% OPA-15406 Ointment

32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 0.3 % OPA-15406 ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.

DRUG

1% OPA-15406 Ointment

32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 1 % OPA-15406 ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose

DRUG

3% OPA-15406 Ointment

32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 3 % OPA-15406 ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.

DRUG

Placebo Ointment

32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration periodriod, subjects were treated with assigned placebo ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned placebo ointment twice daily for 14 days and assessed until 48 hours post dose.

Trial Locations (1)

Unknown

Kanto Region

All Listed Sponsors
lead

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY