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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
single intravenous administration of revacept (PR-15), an inhibitor of platelet adhesion, in various strengths (10, 20, 40, 80, 160 mg) in healthy male volunteers.
ABX-CRO/Medifacts GmbH
Görlitz, Saxony, Germany
safety and tolerability adverse events (AEs), vital signs (BP/PR), 12 lead ECG, bleeding time, antibody titer and safety laboratory tests
Time frame: 43 days
pharmacokinetics and pharmacodynamics (agonist-induced platelet aggregation)
Time frame: 43 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.