Overview

Research Into the Effect of a Clot-dissolving Agent and Its Inhibitor

Status:
Terminated
Trial end date:
2012-10-01
Target enrollment:
Participant gender:
Summary
Single-chain urokinase-type plasminogen activator (pro-urokinase) is a highly effective thrombolytic drug. At pharmacologic concentrations however, pro-urokinase is converted to urokinase - a non specific thrombolytic, limiting its therapeutic use. Mutant pro-urokinase (M5) is more stable and its conversion to urokinase is inhibited by C1-inhibitor. The primary objectives of the study are: - To assess the overall safety and tolerability related to systemic plasminogen activation of single doses of M5 over a wide dose range (study part I). - To assess the effect of single doses of C1-inhibitor on the overall safety and tolerability of single doses of M5 and its effect on M5-induced coagulation changes (study part II).
Phase:
Early Phase 1
Details
Lead Sponsor:
TSI, LLC