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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

NCT00542529 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2007-10-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • HiberCell, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-11-30
Completion
2006-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00542529 on ClinicalTrials.gov