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 | Completed Phase 1 DMC

• 1 other identifier: BT-CL-PGG-SCM0611
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• -To determine the safety of Imprime PGG when dosed as part of a standard 4-day regimen of G-CSF assessed via occurrence of adverse events and change from baseline in clinical laboratories, physical examination, vital signs and ECG

  Prospective

Secondary Outcomes (1)

• -To evaluate the progenitor cell mobilizing efficacy of Imprime PGG when dosed as part of a standard 4-day progenitor cell mobilizing regimen of G-CSF assessed through peripheral blood CD34+ cell counts

  Prospective

Study Arms (2)

Cohort 1

PLACEBO COMPARATOR

Placebo or 2.0 mg/kg of Imprime PGG dosed in 7 different treatment regimens in combination with G-CSF for up to 4 consecutive days.

Biological: Imprime PGG TM for Injection

Cohort 2

PLACEBO COMPARATOR

Placebo or 4.0 mg/kg of Imprime PGG dosed in 7 different treatment regimens in combination with G-CSF for up to 4 consecutive days.

Biological: Imprime PGG TM for Injection

Interventions

Imprime PGG TM for Injection BIOLOGICAL

Doses of 2.0 and 4.0 mg/kg intravenous Imprime PGG administered over 1-2 hr for up to 4 consecutive days

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be between the ages of 18 and 45, inclusive
• Have a body weight of 45 kg to 125 kg, inclusive, and a body mass index less than or equal to 30 kg/m2
• Be healthy based on medical history, physical examination, electrocardiogram (ECG), and clinical laboratory test results
• If female, be non-pregnant and non-nursing. For either gender, the subject must be either sexually inactive (14 days prior to the first dose of study drug and throughout the study) or practicing at least two methods of birth control from the following list of acceptable forms of contraception:
• Surgically sterile subject or partner (bilateral tubal ligation, hysterectomy, bilateral oophorectomy or vasectomy performed at least 6 months prior to first dose of study drug)
• Intrauterine device (IUD) in place for at least 3 months
• Barrier methods (condom, diaphragm) with spermicide from the time of the subject/partner's last menstrual period and throughout the study
• Hormonal contraceptives for at least 3 months prior to the first dose of study drug
• Has read, understood and signed the IRB-approved informed consent form (ICF)

You may not qualify if:

• Has a known hypersensitivity to baker's yeast, G-CSF, or E.coli-derived proteins, or has an active yeast infection
• Has a history of tobacco use within 90 days of the last day of screening (Day -1) or be a known or suspected abuser of alcohol or other drugs/substances of abuse
• Has a positive hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) test conducted as part of screening
• Except as otherwise indicated, has taken any prescription medication within 30 days of the last day of screening (Day -1) or over-the-counter medication, herbal preparation, or vitamins within 7 days of the last day of screening (Day -1)
• Has participated in an investigational drug study within 30 days or five half-lives (whichever is longer) of the last day of screening (Day -1), has received G-CSF within 30 days of the last day of screening, or has ever participated in a study with Imprime PGG or Betafectin®
• Has donated or lost more than a unit of blood within 30 days of the last day of screening (Day -1)

Sponsors & Collaborators

• HiberCell, Inc.: lead

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 10, 2007
• First Posted: October 11, 2007
• Study Start: November 1, 2006
• Study Completion: December 1, 2006
• Last Updated: October 11, 2007

Record last verified: 2007-10