drugset / Trial / NCT01194934
NOX-A12 Multiple Ascending Dose Study in Healthy Volunteers
Non-randomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2010-08
- Primary completion
- 2011-01
- Completion
- 2011-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olaptesed pegol | Oligonucleotide (other) | 2 mg/kg | Intravenous |
| Subject | Olaptesed pegol | Oligonucleotide (other) | 4 mg/kg | Intravenous |
| Comparator | filgrastim | Protein / enzyme biologic | 5 ug/kg | — |