臨床研究等提出・公開システム

Scientific Title	A Phase 1, single-dose and multiple-dose study of DS-2319b inhalation powder to assess the safety and pharmacokinetics of DS-2319a in healthy Japanese subjects (COVID-19)
Public Title	A Phase 1, single-dose and multiple-dose study of DS-2319b inhalation powder to assess the safety and pharmacokinetics of DS-2319a in healthy Japanese subjects

Contact for Scientific Queries	Name	Inoguchi Akihiro
	Affiliation	DAIICHI SANKYO Co.,Ltd.
	Address	1-2-58, Hiromachi, Shinagawa-ku, Tokyo
	Telephone	+81-3-6225-1111
	E-mail	dsclinicaltrial@daiichisankyo.co.jp
Contact for Public Queries	Name	Contact for Clinical Trial Information
	Affiliation	DAIICHI SANKYO Co.,Ltd.
	Address	1-2-58, Hiromachi, Shinagawa-ku, Tokyo
	Telephone	+81-3-6225-1111
	E-mail	dsclinicaltrial@daiichisankyo.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Mar. 10, 2021
Actual date of first enrollment		Mar. 11, 2021
Target sample size		76
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	1. Japanese healthy male subjects. 2. Age >=20 and <=45 years upon providing informed consent. 3. Body mass index (BMI) >=18.5 and <25.0 kg/m2 at screening.
	Exclusion Criteria	1. Having a history of hypersensitivity to any drugs or substances, or being idiosyncratic (eg, having penicillin allergy) 2. Having alcohol or drug dependence etc.
	Age Minimum	20age old over
	Age Maximum	45age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		SARS-CoV-2 Infectious Disease
Intervention(s)		10 to 120 mg of DS-2319b or Placebo is administered at a single inhalation, or an appropriate dose of DS-2319b within the dose range as stated above or Placebo is administered at multiple inhalation.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Safety:AEs, laboratory data, body weight, vital signs, 12-lead ECGs, and chest X-ray
Secondary Outcome(s)		PK:Concentration of plasma DS-2319a and PK parameters for plasma DS-2319a

Primary Sponsor	DAIICHI SANKYO Co.,Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Medical Corporation Heishinkai OPHAC Hospital IRB
Address	4-1-9,Miyahara,Yodogawa-ku,Osaka-shi, Osaka
Telephone	+81-6-6395-9000
E-Mail
Approval Status	Approval
Date of approval	Mar. 09, 2021

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