NOX-A12 Multiple Ascending Dose Study in Healthy Volunteers
Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
Summary
This is the second clinical study of NOX-A12. This study intends to provide information on
the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of repeated
intravenous doses of NOX-A12 (2.0 and 4.0 mg/kg/d) alone and to compare the mobilization of
hematopoietic stem cells (HSC) obtained with NOX-A12 alone with that obtained in combination
with filgrastim in healthy subjects. A single center, open-label, repeated dose study design
is selected to best address the study objectives.The results from this study will establish
the basis for further development of NOX-A12 in lymphoma patients undergoing autologous
hematopoietic stem cell transplantation