臨床研究等提出・公開システム

Date of registration	Sept. 18, 2014
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222603

Scientific Title	Phase I study of TMS-007 in healthy adult male
Public Title	Phase I sutdy of TMS-007

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	TMS Co., Ltd.
	Address	+81-42-306-5078, tms@tms-japan.co.jp
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	TMS Co., Ltd.
	Address	+81-42-306-5078, tms@tms-japan.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		40
Study Type		Interventional
Study Design	Study Design	A randomized, double-blind, placebo-controlled, single intravenous administration, dose escalation study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	Healthy male volunteers
	Exclusion Criteria	1) Serious medical history 2) High risk of bleeding 3) Drug-dependence 4) Allergy to medical drug or constituents of the test drug formulation 5) Major surgery within past 3 months
	Minimum Age	20age old over
	Maximum Age	45age old under
	Gender	Male
Health Condition or Problem Studied		Acute ischemic stroke
Intervention(s)		investigational material(s) Generic name etc : TMS-007 INN of investigational material : Therapeutic category code : 339 Other agents relating to blood and body fluides Dosage and Administration for Investigational material : Intravenous injection, 3, 15, 60, 180, 360 mg/man
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Safety and tolerability Adverse event; 12-lead electrocardiogram; vital signs (body temperature, blood pressure, heart rate, respiratory rate); laboratory tests, brain MRI
Secondary Outcome		1) Pharmacokinetics; 2)Pharmacodynamics 1) Plasma and urinary concentration of TMS-007 and pharmacokinetic parameters 2) Blood markers (FDP, D-dimer, IL-6, TNF-alpha, MMP-9)

Primary Sponsor	TMS 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-142654
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Nov. 06, 2015	Detail	Changes
7	Nov. 06, 2015	Detail	Changes
6	Mar. 03, 2015	Detail	Changes
5	Mar. 03, 2015	Detail	Changes
4	Dec. 25, 2014	Detail	Changes
3	Dec. 25, 2014	Detail	Changes
2	Sept. 18, 2014	Detail	Changes
1	Sept. 18, 2014	Detail

List of change history