Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Safety, Pharmacodynamics, and Pharmacokinetics Study of Intravenous Imprime PGG™ Injection in Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- HiberCell, Inc.
- Enrollment
- 24
- Primary Endpoint
- Evaluate the safety and tolerability of a single intravenous dose of Imprime PGG™ Injection (Imprime PGG) versus placebo when administered to healthy adult subjects by assessing the frequency, type, and severity of adverse events.
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
The purpose of this trial is to the assess the safety, pharmacodynamics, and pharmacokinetics of escalating doses of Imprime PGG™ Injection in healthy volunteers.
Detailed Description
The primary objective of this study is to evaluate the safety and tolerability of a single intravenous dose of Imprime PGG versus placebo when administered to healthy adult subjects by assessing the frequency, type, and severity of treatment emergent adverse events. The secondary objectives are: 1. to determine the pharmacodynamics of a single intravenous dose of Imprime PGG when administered to healthy adult subjects by assessing the number of subjects who experience a 15% or more increase from baseline in the percentage of neutrophils with primed CR3; and 2. to derive the pharmacokinetic profile of a single intravenous dose of Imprime PGG when administered to healthy adult subjects by assessing the plasma concentration of Imprime PGG versus time.
Investigators
Eligibility Criteria
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 nonpregnant and nonnursing, and if premenopausal, have a negative urine 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, the physical examination, electrocardiogram, and clinical laboratory test results
- •Have the ability to understand the requirements of the study, have provided 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 the Screening Period
- •Be a known or suspected abuser of alcohol or other drugs of abuse
- •Have an active yeast infection
- •Have a positive hepatitis B, hepatitis C, or human immunodeficiency virus test during the Screening Period
- •Except as otherwise indicated, have taken any prescription medication within 14 days of study drug administration on Day 0 or over-the-counter medication, herbal preparation, or vitamins within 1 week of study drug administration on Day 0 (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 Screening Period
- •Have donated or lost more than a unit of blood within 30 days of the Screening Period
- •Have any clinical condition that, in the opinion of the principal investigator, warrants exclusion from the study for either a scientific, procedural, or safety perspective
Outcomes
Primary Outcomes
Evaluate the safety and tolerability of a single intravenous dose of Imprime PGG™ Injection (Imprime PGG) versus placebo when administered to healthy adult subjects by assessing the frequency, type, and severity of adverse events.
Time Frame: Prospective
Secondary Outcomes
- -To determine the pharmacodynamics of a single intravenous dose 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 3 (CR3)(Prospective)
- To derive the pharmacokinetic profile of a single intravenous dose of Imprime PGG, when administered to healthy adult subjects, by assessing the plasma concentration of Imprime PGG versus time.(Prospective)