Research Into the Effect of a Clot-dissolving Agent and Its Inhibitor
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).
Acute Ischemic Stroke
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Phase 1 Trial of Mutant proUK, M5, and Its Inhibitor, C1-inhibitor|
- Changes to vital signs, routine safety laboratory results, or ECG-findings [ Time Frame: -42d, -14h, -15', 15', 30', 45',60', 90', 10h, 24h, 48h, 7d ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||September 2015|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
|mutant pro-urokinase (M5) alone|
|Mutant pro-urokinase (M5) and its inhibitor, C1 inhibitor|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01694381
|Center for Human Drug Research|
|Leiden, Netherlands, 2333|
|Principal Investigator:||Koos Burggraaf, MD, PhD||Center for Human Drug Research|