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

Phase I/II, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Single-Center Study of the Progenitor Cell Mobilizing Effects of Imprime PGG™ Injection Administered at Varied Dosing Regimens With G-CSF Versus G-CSF Alone in Healthy Subjects

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: HiberCell, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Imprime PGG TM for Injection	Doses of 2.0 and 4.0 mg/kg intravenous Imprime PGG administered over 1-2 hr for up to 4 consecutive days

Timeline

• Start date: 2006-11-01
• Completion: 2006-12-01
• First posted: 2007-10-11
• Last updated: 2007-10-11