Why the study?
TMS-007 showed efficacy in experimental stroke models, but its safety, pharmacokinetics, and pharmacodynamics had not yet been evaluated in humans.
Does a single intravenous infusion of TMS-007 demonstrate safety and favorable pharmacokinetics in healthy male subjects?
Population
Five completed cohorts of healthy male Japanese subjects (n=8 per cohort)
Comparison
Single intravenous infusion of TMS-007 (3, 15, 60, 180, or 360 mg) vs placebo
Design
Randomized, placebo-controlled, double-blind, dose-escalation study
Authors
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TMS-007 well tolerated with favorable PK in healthy volunteers; supports advancement to efficacy trials in stroke.
Does a single intravenous infusion of TMS-007 demonstrate safety and favorable pharmacokinetics in healthy male subjects?
TMS-007, a novel profibrinolytic agent, is safe and well-tolerated in healthy volunteers, supporting its further clinical development for thrombotic and embolic strokes.
Moritoyo et al. (2022) studied this question.
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