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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 PGGâ„¢ Injection in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Placebo Comparator | 1.0 mg/kg Imprime PGG administered daily over 1 hr for 7 consecutive days |
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| Cohort 2 | Placebo Comparator | 2.0 mg/kg Imprime PGG administered daily over 1 hr for 7 consecutive days |
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| Cohort 3 | Placebo Comparator | 4.0 mg/kg Imprime PGG administered daily over 2 hr for 7 consecutive days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imprime PGG TM for Injection | Biological | Doses of 1.0 mg/kg-4.0 mg/kg of Imprime PGG administered over 1-2 hr for 7 consecutive days |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Prospective |