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

NCT01694381 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-01-19

No results posted yet for this study

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).

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

M5

single point mutant of serine protease prourokinase

DRUG

C1-inhibitor

a protease inhibitor belonging to the serpin superfamily.

Sponsors & Collaborators

  • TSI, LLC

    lead INDUSTRY

Principal Investigators

  • Koos Burggraaf, MD, PhD · Center for Human Drug Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01694381 on ClinicalTrials.gov