臨床研究等提出・公開システム

Scientific Title	DS-6016a Phase I Study - Single ascending dose study to assess the safety, tolerability, and pharmacokinetics of DS-6016a after subcutaneous injection in healthy Japanese subjects. -
Public Title	DS-6016a Phase I Study - Single ascending dose study to assess the safety, tolerability, and pharmacokinetics of DS-6016a after subcutaneous injection 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. 20, 2021
Actual date of first enrollment		April. 01, 2021
Target sample size		48
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		Fibrodysplasia ossificans progressiva
Intervention(s)		DS-6016a or Placebo is administered at a single subcutaneous injection into the upper arm, upper part of the thigh, or abdominal wall.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Safety: Adverse Events, laboratory data, body weight, vital signs, and 12-lead Electrocardiography
Secondary Outcome(s)		-Plasma pharmacokinetics parameters for DS-6016a -Formation of anti-drug antibody and anti-host cell protein antibody

Primary Sponsor	DAIICHI SANKYO Co.,Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Japan Agency for Medical and Development
Secondary Sponsor	Not applicable

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

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT04818398
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history