Phase 1, Single and Multiple Topically Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of M119102 in Healthy Adult Subjects.

JRCT ID: jRCT2071220006

Registered date:23/04/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Alopecia Areata
• Date of first enrollment: 09/05/2022
• Target sample size: 16
• Study type: Interventional
• Intervention(s): 10% M119102 or M119102 placebo will be administered to the back of subjects singlely or twice a day for 2 weeks.

Outcome(s)

• Primary Outcome: Safety, Pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 44age old
• Gender: Male

Include criteria

(1)Healthy men who are 20 to 44 years of age at the time of informed consent.
(2)BMI of 18.5 to 24.9 kg/m2

Exclude criteria

(1)Individuals with a history or merger of hepatic, renal, cardiac and other cardiovascular, gastrointestinal, hematologic, blood, endocrine, respiratory, or other diseases considered inappropriate for paticipation in the clinical study.
(2)Individuals who are judged to be clinically abnormal by the principal (sub) investigator based on clinical tests, vital signs, and electrocardiogram.
(3)Individuals who are judged to be unsuitable as subject by the principal (sub) investigator.

Related Information

• Primary Sponsor: Tomoyuki Nishiura