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Phase I sutdy of TMS-007

Phase I study of TMS-007 in healthy adult male

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222603
Enrollment
40
Registered
2014-09-18
Start date
2014-09-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke

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.
Lead Sponsor

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

MeasureTime frame
Safety and tolerability Adverse event; 12-lead electrocardiogram; vital signs (body temperature, blood pressure, heart rate, respiratory rate); laboratory tests, brain MRI

Secondary

MeasureTime 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

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026