Multiple-Dose, Dose-Escalation Safety, Pharmacodynamics, and Pharmacokinetics Study of Imprime PGG™ Injection
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Biological: Imprime PGG TM for Injection
- Registration Number
- NCT00542464
- Lead Sponsor
- HiberCell, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- Be aged 18 to 45 years, inclusive
- Have a body weight of 45 to 125 kg, inclusive, and a body mass index less than or equal to 30 kg/m2
- 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
- Be healthy as determined by the investigator on the basis of medical history, physical examination, electrocardiogram, and clinical laboratory test results
- 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
- Have provided written authorization for use and disclosure of protected health information
Exclusion Criteria
- Have a known hypersensitivity to baker's yeast
- Have a history of tobacco use within 3 months of first day of screening
- Be a known or suspected abuser of alcohol or other drugs/substances of abuse at anytime
- Have an active yeast infection
- Have a positive hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) test conducted as part of screening
- 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
- 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
- Have donated or lost more than a unit of blood within 30 days of the last day of screening (Day -1)
- Have any clinical condition that, in the opinion of the principal investigator, warrants exclusion from the study from a scientific, procedural, or safety perspective
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 Imprime PGG TM for Injection 2.0 mg/kg Imprime PGG administered daily over 1 hr for 7 consecutive days Cohort 3 Imprime PGG TM for Injection 4.0 mg/kg Imprime PGG administered daily over 2 hr for 7 consecutive days Cohort 1 Imprime PGG TM for Injection 1.0 mg/kg Imprime PGG administered daily over 1 hr for 7 consecutive days
- Primary Outcome Measures
Name Time Method 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). Prospective
- Secondary Outcome Measures
Name Time Method -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). 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. Prospective