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

NCT01806077 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-04-21

No results posted yet for this study

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

DRUG

PZ-128

Sequential single-dose escalation; 1 to 2 hour continuous intravenous infusion

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Sinai Hospital of Baltimore

    collaborator OTHER

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Paul A. Gurbel, MD · Sinai Hospital of Baltimore (Sinai Center for Thrombosis Research)

  • Athan Kuliopulos, MD, PhD · Tufts Medical Center (Hemostasis and Thrombosis Laboratory)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

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 NCT01806077 on ClinicalTrials.gov