Single ascending dose and multiple ascending dose study of M132101 in healthy subjects.

JRCT ID: jRCT2071230113

Registered date:08/02/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: infantile hemangioma
• Date of first enrollment: 08/02/2024
• Target sample size: 48
• Study type: Interventional
• Intervention(s): M132101 or placebo will be topically applied once or twice a day for 7 days

Outcome(s)

• Primary Outcome: Tolerability, Safety, PK

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 45age old
• Gender: Male
• Include criteria: Males who are 18 to 44 years of age at the time of informed consent

Exclude criteria

(1)Individuals with a history or complications with liver, kidney, or heart disease, etc. considered inappropriate for participation in the clinical study
(2)Individuals with abnormal findings (eczema/dermatitis, pigment abnormalities, inflammation due to sunburn, wounds, scars, skin infections, etc.) at the administration site.
(3)Individuals who are judged to be unsuitable as subject by the principal (sub) investigator

Related Information

• Primary Sponsor: Nishiura Tomoyuki