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The purpose of this trial is to the assess the safety, pharmacodynamics, and pharmacokinetics of escalating doses of Imprime PGGâ„¢ Injection in healthy volunteers.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Placebo Comparator | Single dose of 0.5 mg/kg Imprime PGG administered over 1 hr |
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| Cohort 2 | Placebo Comparator | Single dose of 1.0 mg/kg Imprime PGG administered over 1 hr |
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| Cohort 3 | Placebo Comparator | Single dose of 2.0 mg/kg Imprime PGG administered over 1 hr |
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| Cohort 4 | Placebo Comparator | Single dose of 4.0 mg/kg Imprime PGG administered over 2 hr |
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| Cohort 5 | Placebo Comparator | Single dose of 6.0 mg/kg Imprime PGG administered over 3 hr |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imprime PGG | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and tolerability of a single intravenous dose of Imprime PGGâ„¢ Injection (Imprime PGG) versus placebo when administered to healthy adult subjects by assessing the frequency, type, and severity of adverse events. | Prospective |
| Measure | Description | Time Frame |
|---|---|---|
| -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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Prospective |