drugset / Trial / NCT01543971
Safety and Efficacy of TXA127 and Neupogen to Increase Peripheral Blood Stem Cells (PBSCs)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a Phase I Study to be conducted in 18 healthy volunteers. Each will receive daily injections for 5 days of TXA127 alone, or Neupogen alone, or TXA127 plus Neupogen together. The aim of the study is to determine the safety of the TXA127 alone and in combination with Neupogen, and to determine whether the use of TXA127 alone or in combination with Neupogen enhances peripheral blood stem cell (CD34+)mobilization.
Timeline
- Start
- 2009-12
- Primary completion
- 2009-12
- Completion
- 2010-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Neupogen : 10mcg/kg per day for 5 days, injection | Unknown | 10 ug/kg | Subcutaneous |
| Comparator | talfirastide | Peptide | 300 ug/kg | Subcutaneous |
Indications
No indication recorded.