臨床研究等提出・公開システム

Date of registration	May. 19, 2022
Last modified on	Aug. 31, 2022
Trial ID	jRCT2031220073

Scientific Title	A Phase I, Single-dose Study with SB206 in Healthy Japanese Adults
Public Title	A Phase I, Single-dose Study with SB206 in Healthy Japanese Adults

Contact for Scientific Queries	Name	Tsubouchi Ichiro
	Affiliation	Sato Pharmaceutical Co., Ltd.
	Address	1-5-27, Motoakasaka, Minato-Ku, Tokyo
	Telephone	+81-3-5412-7329
	E-mail	clinicaltrials-info@sato-seiyaku.co.jp
Contact for Public Queries	Name	Clinical Trials Information Desk
	Affiliation	Sato Pharmaceutical Co., Ltd.
	Address	1-5-27, Motoakasaka, Minato-Ku, Tokyo
	Telephone	+81-3-5412-7329
	E-mail	clinicaltrials-info@sato-seiyaku.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		May. 01, 2022
Actual date of first enrollment		June. 23, 2022
Target sample size		20
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	placebo control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1. Healthy Japanese adult males aged 20 to 40 years at the time of obtaining written informed consent 2. Subjects with a body mass index (BMI) of 18.5 to 25.0 at screening 3. Subjects who are considered by the investigator or subinvestigator as acceptable for inclusion in the study as judged from the results of observation and examination upon screening and hospitalization 4. Subjects who received full explanations regarding the objective of the study, details of the study and the study drug and provided voluntary written informed consent
	Exclusion Criteria	1. Subjects with a history of drug allergy 2. Subjects with a history of food allergy 3. Subjects with a history of contact dermatitis, such as adhesive tape dermatitis, or mechanical urticaria 4. Subjects considered ineligible for the study by the investigator or subinvestigator
	Age Minimum	20age old over
	Age Maximum	40age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Molluscum contagiosum
Intervention(s)		SB206 and vehicle are applied.
Primary Outcome(s)		Skin irritation

Primary Sponsor	Sato Pharmaceutical Co., Ltd.

Name of Certified Review Board	Medical Corporation Shinanokai Shinanozaka Clinic Institutional Review Board
Address	Yotsuya Medical-building, 20 Samoncho, Shinjuku-Ku, Tokyo
Telephone	+81-3-5366-3006
E-Mail	scl-irb@shinanokai.com
Approval Status	Approval
Date of approval	May. 25, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Aug. 31, 2022	(this page)	Changes
1	May. 19, 2022	Detail

List of change history