Phase I sutdy of TMS-007

Phase 1

• Conditions: Acute ischemic stroke

• Registration Number: JPRN-jRCT2080222603
• Lead Sponsor: TMS Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability<br>Adverse event; 12-lead electrocardiogram; vital signs (body temperature, blood pressure, heart rate, respiratory rate); laboratory tests, brain MRI

Secondary Outcome Measures

Name	Time	Method
1) Pharmacokinetics; 2)Pharmacodynamics<br>1) Plasma and urinary concentration of TMS-007 and pharmacokinetic parameters<br>2) Blood markers (FDP, D-dimer, IL-6, TNF-alpha, MMP-9)