Phase I study to determine and compare the safety/tolerability of single ascending doses of POL6326 by intravenous infusion.
Phase I Study * to determine and compare the safety of single ascending doses of POL6326 by intravenous infusion * to determine the relationship between 2-hour single intravenous infusion doses of POL6326 and the concentration of HSC and mature WBC in peripheral blood using immunophenotypic assays.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
German Red Cross Blood Service and Institute for Transfusion Medicine and Immunohematology of the Goethe University
Frankfurt, Germany
Safety of single ascending doses of POL6326 by intravenous infusion according to standard criteria
Safety as measured by the incidence, type and severity of adverse events.
Time frame: 2 days
Pharmacokinetic outcome
Determine the pharmacokinetic profile of POL6326 following single intravenous administration, e.g. Cmax, AUC, terminal half life and clearance
Time frame: 24h
Mobilisation of CD34+ cells
Time dependent measurement of CD34+ cells during and after infusion of POL6326 in all subjects
Time frame: 2 days
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