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).
- Observation: Cohort
- Perspective: Prospective
- Sampling: Non-Probability Sample
|Type||Measure||Time Frame||Safety Issue|
|Primary||Changes to vital signs, routine safety laboratory results, or ECG-findings||-42d, -14h, -15', 15', 30', 45',60', 90', 10h, 24h, 48h, 7d||Yes|
Biospecimen Retention:Samples Without DNA - plasma samples.
- TSI, LLC Lead