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

A Phase 1,randomized,placebo-controlled,double-blind, single ascending dose and multiple ascending dose study of M132101 in healthy subjects.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2071230113
Enrollment
48
Registered
2024-02-08
Start date
2024-03-08
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

infantile hemangioma

Interventions

M132101 or placebo will be topically applied once or twice a day for 7 days

Sponsors

Nishiura Tomoyuki
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Males who are 18 to 44 years of age at the time of informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Tolerability, Safety, PK

Contacts

Public ContactClinical Trials Information -

Maruho Co.,Ltd. Kyoto R&D Center

ctinfo@mii.maruho.co.jp+81-75-325-3279

Outcome results

None listed

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