Phase Ia Dose-Escalation Safety, Pharmacodynamic and Pharmacokinetic Study of Imprime PGG™ Injection

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:

• 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
• 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.

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