NCT01806077

Safety Study of PZ-128 in Subjects With Multiple Coronary Artery Disease Risk Factors

Demonstration of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Antiplatelet Effect of PZ-128 in Subjects With Multiple Coronary Artery Disease Risk Factors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase I, intravenous, single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PZ-128 (pepducin inhibitor of PAR1) in subjects with vascular disease or who have 2 or more coronary artery disease (CAD) risk factors.

Conditions

• Vascular Disease
• Coronary Artery Disease Risk Factors Multiple

Interventions

Type	Name	Description
DRUG	PZ-128	Sequential single-dose escalation; 1 to 2 hour continuous intravenous infusion

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2013-03-07
• Last updated: 2016-04-21

Locations

1 site across 1 country: United States