drugset / Trial / NCT00542529
Phase I/II, Randomized, Double-Blind, Study of the Progenitor Cell Mobilizing Effects of Imprime PGG™ Injection Administered at Varied Dosing Regimens With G-CSF Versus G-CSF Alone
RandomizedParallel-groupTriple-blind
Summary
This study is a randomized, placebo-controlled, dose-escalation, single-center study evaluating two different doses of Imprime PGG, each in 7 different dosing regimes. A total of 66 subjects will be enrolled into 2 cohorts and, within each cohort, randomized to 1 of 7 treatment groups receiving Imprime PGG or placebo in varied dosing regimens with granulocyte-colony stimulating factor (G-CSF).
Timeline
- Start
- 2006-11
- Primary completion
- —
- Completion
- 2006-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Imprime PGG | Other / unclassified | 2 mg/kg | Intravenous |
| Comparator | Imprime PGG | Other / unclassified | 4 mg/kg | Intravenous |
Indications
No indication recorded.