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

2014-08-27 03:16:53 | BioPortfolio

Summary

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

Description

Primary objective:

To evaluate safety and tolerability by using adverse events (AEs), vital signs including blood pressure/pulse rate (BP/PR), electrocardiographic examinations (12 lead ECG), bleeding time, evaluation of antibody titer and safety laboratory tests (biochemistry, hematology, coagulation, urinalysis)

Secondary objectives:

To evaluate the pharmacokinetics and pharmacodynamics (collagen-induced platelet aggregation)of six ascending single intravenous doses of PR-15 in healthy, male volunteers

Study Design

Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Thrombosis

Intervention

revacept (PR-15)

Location

ABX-CRO/Medifacts GmbH
Goerlitz
Saxonia
Germany
02826

Status

Completed

Source

Corimmun GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:53-0400

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