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Multiple-Dose, Dose-Escalation Safety, Pharmacodynamics, and Pharmacokinetics Study of Imprime PGG™ Injection

This study has been completed.
Sponsor:
Information provided by:
Biothera
ClinicalTrials.gov Identifier:
NCT00542464
First received: October 10, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted

October 10, 2007
October 10, 2007
May 2006
Not Provided
To evaluate the safety and tolerability of 7 consecutive daily i.v. doses of Imprime PGG versus placebo when administered to healthy adult subjects by assessing the frequency, type, and severity of treatment-emergent adverse events (AE). [ Time Frame: Prospective ]
Same as current
No Changes Posted
  • -To determine the pharmacodynamics of 7 consecutive daily intravenous doses of Imprime PGG by assessing the number of subjects who experience a 15% or more increase from baseline in the percentage of neutrophils with primed complement receptor (CR3). [ Time Frame: Prospective ]
  • -To derive the pharmacokinetic profile of 7 consecutive daily intravenous doses of Imprime PGG when administered to healthy adult subjects by assessing the plasma concentration of Imprime PGG versus time profiles. [ Time Frame: Prospective ]
Same as current
Not Provided
Not Provided
 
Multiple-Dose, Dose-Escalation Safety, Pharmacodynamics, and Pharmacokinetics Study of Imprime PGG™ Injection
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Safety, Pharmacodynamics, and Pharmacokinetics Study of Intravenous Imprime PGG™ Injection in Healthy Adult Subjects

The study is a Phase Ib, randomized, double-blind, placebo-controlled, multiple-dose (7 day), dose-escalation study assessing the safety, pharmacodynamics, and pharmacokinetics of intravenous Imprime PGG™ Injection in healthy adult subjects.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Healthy
Biological: Imprime PGG TM for Injection
Doses of 1.0 mg/kg-4.0 mg/kg of Imprime PGG administered over 1-2 hr for 7 consecutive days
  • Placebo Comparator: Cohort 1
    1.0 mg/kg Imprime PGG administered daily over 1 hr for 7 consecutive days
    Intervention: Biological: Imprime PGG TM for Injection
  • Placebo Comparator: Cohort 2
    2.0 mg/kg Imprime PGG administered daily over 1 hr for 7 consecutive days
    Intervention: Biological: Imprime PGG TM for Injection
  • Placebo Comparator: Cohort 3
    4.0 mg/kg Imprime PGG administered daily over 2 hr for 7 consecutive days
    Intervention: Biological: Imprime PGG TM for Injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
September 2006
Not Provided

Inclusion Criteria:

  1. Be aged 18 to 45 years, inclusive
  2. Have a body weight of 45 to 125 kg, inclusive, and a body mass index less than or equal to 30 kg/m2
  3. If female, be non-pregnant and non-nursing, and if pre-menopausal, have a negative serum pregnancy test confirmed prior to enrollment and practicing at least two methods of birth control
  4. Be healthy as determined by the investigator on the basis of medical history, physical examination, electrocardiogram, and clinical laboratory test results
  5. Have the ability to understand the requirements of the study, provide written informed consent, and agree to abide by the study restrictions and to return for the required assessments
  6. Have provided written authorization for use and disclosure of protected health information

Exclusion Criteria:

  1. Have a known hypersensitivity to baker's yeast
  2. Have a history of tobacco use within 3 months of first day of screening
  3. Be a known or suspected abuser of alcohol or other drugs/substances of abuse at anytime
  4. Have an active yeast infection
  5. Have a positive hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) test conducted as part of screening
  6. Except as otherwise indicated, have 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); the following medications are exempted from this criterion: acetaminophen [maximum 3 g/day], female hormone replacement therapy, and oral contraceptives
  7. Have participated in an investigational drug study within 30 days or five half lives (whichever is longer) of the last day of screening (Day -1) or have ever participated in a study with Imprime PGG or Betafectin
  8. Have donated or lost more than a unit of blood within 30 days of the last day of screening (Day -1)
  9. Have any clinical condition that, in the opinion of the principal investigator, warrants exclusion from the study from a scientific, procedural, or safety perspective
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00542464
BIOBG-CL-002
Yes
Not Provided
Biothera
Not Provided
Not Provided
Biothera
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP