Safety, Pharmacokinetic and -Dynamic Study of PR-15, an Inhibitor of Platelet Adhesion "PR-15/01"


Phase 1 Results N/A

Summary of Purpose

Primary objective: To evaluate safety and tolerability, adverse events (AEs), vital signs, ECG, bleeding time, evaluation of antibody titer and safety laboratory tests Secondary objectives: To evaluate the pharmacokinetics and pharmacodynamics (platelet aggregation)of six ascending single intravenous doses of PR-15 in healthy volunteers

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 18 October 2012.

1 Mar 2006 5 Jan 2010 1 Jan 2007 1 Oct 2007 1 Oct 2012 Unavailable
Start Date First Received 1st Completion Completion Verification Results

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Pharmacokinetics/Dynamics Study
  • Intervention: Single Group Assignment


Not available