NCT00542464CompletedPhase 1
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Safety, Pharmacodynamics, and Pharmacokinetics Study of Intravenous Imprime PGG™ Injection in Healthy Adult Subjects
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- HiberCell, Inc.
- Enrollment
- 12
- Primary Endpoint
- 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).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Cohort 1
Placebo Comparator
1.0 mg/kg Imprime PGG administered daily over 1 hr for 7 consecutive days
Intervention: Imprime PGG TM for Injection (Biological)
Cohort 2
Placebo Comparator
2.0 mg/kg Imprime PGG administered daily over 1 hr for 7 consecutive days
Intervention: Imprime PGG TM for Injection (Biological)
Cohort 3
Placebo Comparator
4.0 mg/kg Imprime PGG administered daily over 2 hr for 7 consecutive days
Intervention: Imprime PGG TM for Injection (Biological)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- -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)
Investigators
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