臨床研究等提出・公開システム

Date of registration	Nov. 19, 2023
Last modified on	April. 21, 2024
Trial ID	jRCT2071230090

Scientific Title	Phase 1, single dose study of M707102 in healthy subjects
Public Title	Single-dose study of M707102 in healthy subjects

Contact for Scientific Queries	Name	Nishiura Tomoyuki
	Affiliation	Maruho Co.,Ltd. Kyoto R&D Center
	Address	93 Chudoji Awatacho, Shimogyo-ku, Kyoto
	Telephone	+81-75-325-3279
	E-mail	ctinfo@mii.maruho.co.jp
Contact for Public Queries	Name	- Clinical Trials Information
	Affiliation	Maruho Co.,Ltd. Kyoto R&D Center
	Address	93 Chudoji Awatacho, Shimogyo-ku, Kyoto
	Telephone	+81-75-325-3279
	E-mail	ctinfo@mii.maruho.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Nov. 19, 2023
Actual date of first enrollment		Feb. 28, 2024
Target sample size		16
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Male subjects from 18 to 49 years of age (at the time of informed consent)
	Exclusion 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
	Age Minimum	18age old over
	Age Maximum	49age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Actinic keratosis
Intervention(s)		M707102 or M707102 vehicle will be applied topically under occlusion
Primary Outcome(s)		Safety, Pharmacokinetics

Primary Sponsor	Maruho Co.,Ltd.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Institutional Review Board of Hakata Clinic
Address	6-18 Tenyamachi, Hakata-ku, Fukuoka
Telephone	+81-92-283-7701
E-Mail	miyako-koga@lta-med.com
Approval Status	Approval
Date of approval	Nov. 30, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	April. 21, 2024	(this page)	Changes
1	Nov. 19, 2023	Detail

List of change history