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Scientific Title	A clinical trial of STN1013600 ophthalmic solution in healthy adult male volunteer for single and repeated dose - Phase I -
Public Title	A phase I study of STN1013600 ophthalmic solution in healthy adult male volunteer

Contact for Scientific Queries	Name	Migita Yukie
	Affiliation	Santen pharmaceutical co.,ltd
	Address	4-20 Ofuka-cho, Kita-ku, Osaka, Japan
	Telephone	+81-6-4802-9341
	E-mail	clinical@santen.co.jp
Contact for Public Queries	Name	Migita Yukie
	Affiliation	Santen pharmaceutical co.,ltd
	Address	4-20 Ofuka-cho, Kita-ku, Osaka, Japan
	Telephone	+81-6-4802-9341
	E-mail	clinical@santen.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Feb. 10, 2022
Actual date of first enrollment		Feb. 18, 2022
Target sample size		24
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Subjects who can comply with scheduled visits, the examination and observation as specified in the clinical study protocol
	Exclusion Criteria	1)Subjects have a disease and/or abnormal laboratory value which is considered inappropriate from safety evaluation perspective 2)Subjects who are inappropriate as participants in this study in the opinion of the investigator or sub investigator
	Age Minimum	20age old over
	Age Maximum	45age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Presbyopia
Intervention(s)		To assess the tolerability of STN1013600 ophthalmic solution, by single dose, dose escalation. Next, to assess the tolerability of STN1013600 ophthalmic solution, by repeat dose which meet safety criteria in single dose.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Safety: Adverse events and adverse drug reactions
Secondary Outcome(s)

Primary Sponsor	Santen pharmaceutical co.,ltd

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	The IRB of Kitasato University Shirokane Campus
Address	5-9-1, Shirokane, Minato-ku, Tokyo, Japan, Tokyo
Telephone	+81-3-5791-6177
E-Mail	irb-pt@insti.kitasato-u.ac.jp
Approval Status	Approval
Date of approval	Jan. 26, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history