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

Study Overview
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Brief Summary
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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.

Official Title
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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
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Healthy

Intervention / Treatment
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* Biological: Imprime PGG TM for Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Cohort 1<br>1.0 mg/kg Imprime PGG administered daily over 1 hr for 7 consecutive days | Biological: Imprime PGG TM for Injection<br>* Doses of 1.0 mg/kg-4.0 mg/kg of Imprime PGG administered over 1-2 hr for 7 consecutive days<br>|
| Placebo Comparator: Cohort 2<br>2.0 mg/kg Imprime PGG administered daily over 1 hr for 7 consecutive days | Biological: Imprime PGG TM for Injection<br>* Doses of 1.0 mg/kg-4.0 mg/kg of Imprime PGG administered over 1-2 hr for 7 consecutive days<br>|
| Placebo Comparator: Cohort 3<br>4.0 mg/kg Imprime PGG administered daily over 2 hr for 7 consecutive days | Biological: Imprime PGG TM for Injection<br>* Doses of 1.0 mg/kg-4.0 mg/kg of Imprime PGG administered over 1-2 hr for 7 consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety in Healthy Adult Subjects