Single-dose study of M707102 in healthy subjects

JRCT ID: jRCT2071230090

Registered date:19/11/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Actinic keratosis
• Date of first enrollment: 28/02/2024
• Target sample size: 16
• Study type: Interventional
• Intervention(s): M707102 or M707102 vehicle will be applied topically under occlusion

Outcome(s)

• Primary Outcome: Safety, Pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 49age old
• Gender: Male
• Include criteria: Male subjects from 18 to 49 years of age (at the time of informed consent)

Exclude criteria

(1) Individuals with a history or complications of any of the following diseases
1)Actinic keratosis, porphyria
2)Photosensitivity, metabolic diseases such as aminoaciduria, idiopathic or immune diseases such as polymorphic light eruption, genetic diseases such as xeroderma pigmentosum, and diseases for which onset or exacerbation occur due to exposure to sunlight such as systemic lupus erythematosus and pemphigus
(2) Individuals with a history of allergy or hypersensitivity (including skin hypersensitivity) to any ingredient or metabolite of the investigational medicinal product
(3) Individuals who are judged to be unsuitable as subject by the principal (sub) investigator

Related Information

• Primary Sponsor: Nishiura Tomoyuki