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

This study has been completed.
Sponsor:
Information provided by:
Biothera
ClinicalTrials.gov Identifier:
NCT00542529
First received: October 10, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Healthy
Biological: Imprime PGG TM for Injection
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: 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

Further study details as provided by Biothera:

Primary Outcome Measures:
  • -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 [ Time Frame: Prospective ]

Secondary Outcome Measures:
  • -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 [ Time Frame: Prospective ]

Enrollment: 66
Study Start Date: November 2006
Study Completion Date: December 2006
Arms Assigned Interventions
Placebo Comparator: Cohort 1
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
Doses of 2.0 and 4.0 mg/kg intravenous Imprime PGG administered over 1-2 hr for up to 4 consecutive days
Placebo Comparator: Cohort 2
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
Doses of 2.0 and 4.0 mg/kg intravenous Imprime PGG administered over 1-2 hr for up to 4 consecutive days

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Be between the ages of 18 and 45, inclusive
  2. Have a body weight of 45 kg to 125 kg, inclusive, and a body mass index less than or equal to 30 kg/m2
  3. Be healthy based on medical history, physical examination, electrocardiogram (ECG), and clinical laboratory test results
  4. 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:

    1. 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)
    2. Intrauterine device (IUD) in place for at least 3 months
    3. Barrier methods (condom, diaphragm) with spermicide from the time of the subject/partner's last menstrual period and throughout the study
    4. Hormonal contraceptives for at least 3 months prior to the first dose of study drug
  5. Has read, understood and signed the IRB-approved informed consent form (ICF)

Exclusion Criteria:

  1. Has a known hypersensitivity to baker's yeast, G-CSF, or E.coli-derived proteins, or has an active yeast infection
  2. Has any clinical condition that, in the opinion of the investigator, warrants exclusion from the study from a scientific, procedural, or safety perspective
  3. 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
  4. Has a positive hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) test conducted as part of screening
  5. 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)
  6. 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®
  7. Has donated or lost more than a unit of blood within 30 days of the last day of screening (Day -1)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00542529     History of Changes
Other Study ID Numbers: BT-CL-PGG-SCM0611
Study First Received: October 10, 2007
Last Updated: October 10, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Biothera:
Healthy Subjects

ClinicalTrials.gov processed this record on September 22, 2014