Single ascending dose and multiple ascending dose study of M132101 in healthy subjects.
Phase 1
- Conditions
- infantile hemangioma
- Registration Number
- JPRN-jRCT2071230113
- Lead Sponsor
- ishiura Tomoyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 48
Inclusion Criteria
Males who are 18 to 44 years of age at the time of informed consent
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tolerability, Safety, PK
- Secondary Outcome Measures
Name Time Method