Acute ischemic stroke
Conditions
Interventions
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
Sponsors
TMS Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Healthy male volunteers
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability Adverse event; 12-lead electrocardiogram; vital signs (body temperature, blood pressure, heart rate, respiratory rate); laboratory tests, brain MRI | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Outcome results
None listed