臨床研究等提出・公開システム

Date of registration	Aug. 24, 2012
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221894

Scientific Title	CS-4771 Phase 1 study - A randomized, double-blind, placebo-controlled, continuous IV infusion for 96 hours, ascending dose study to assess the safety, pharmacokinetics and pharmacodynamics of CS-4771 in Japanese healthy subjects -
Public Title	- A randomized, double-blind, placebo-controlled, continuous IV infusion for 96 hours, ascending dose study to assess the safety, pharmacokinetics and pharmacodynamics of CS-4771 in Japanese healthy subjects -

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO Co.,Ltd.
	Address	http://www.daiichisankyo.co.jp/contact/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		24
Study Type		Interventional
Study Design	Study Design	Single-center, randomized, placebo-controlled, dose-escalation, double-blind study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	- male Japanese - between the age of 20 and 45 - between the BMI of 18.5 and 25.0
	Exclusion Criteria	- A history of serious diseases caused by disorders of the central nervous system, circulatory system, respiratory system, blood/hematopoietic system, gastrointestinal system, hepatic and renal function, thyroid function, pituitary gland function, adrenal function, etc., and the judgment of the investigator or subinvestigator that participation in the clinical study could pose a risk to the subject's safety - MetHB level of 2% or greater, or MetHB value of 0.24 g/dL or greater - Hypersensitivity to methylene blue or Toll-like receptor 4 (TLR4) inhibitors - Inappropriateness for inclusion into the study as judged by the investigator or subinvestigator (for example, subjects who may have difficulty in visiting the study center or ensuring compliance)
	Minimum Age	20age old over
	Maximum Age	45age old under
	Gender	Male
Health Condition or Problem Studied		Healthy male volunteers
Intervention(s)		investigational material(s) Generic name etc : CS-4771 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Continuous IV infusion for 96 hours(3 doses)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Safety, Pharmacodynamic and Pharmacokinetic
Secondary Outcome		To evaluate safety endpoints according to the adverse events, vital signs, 12-lead ECGs and laboratory values. To evaluate pharmacodynamic endpoints according to the release of TNF-a and IL-6 when whole blood is stimulated ex vivo using LPS. To evaluate pharmacokinetic endpoints according to the free form of CS 4771 in plasma.

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-121939
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
5	Dec. 17, 2018	(this page)	Changes
4	Nov. 18, 2013	Detail	Changes
3	Nov. 18, 2013	Detail	Changes
2	Aug. 24, 2012	Detail	Changes
1	Aug. 24, 2012	Detail

List of change history