Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Safety, Pharmacodynamics, and Pharmacokinetics Study of Intravenous Imprime PGG™ Injection in Healthy Adult Subjects
Sponsor study identifier
interventional
24
0 countries
N/A
Study Start
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
April 2006
Actual (reported)The purpose of this trial is to the assess the safety, pharmacodynamics, and pharmacokinetics of escalating doses of Imprime PGG™ Injection in healthy volunteers.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2006
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
April 2006
Actual (reported)October 10, 2007
Actual (reported)October 11, 2007
Actual (reported)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.
Prospective
-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
Single dose of 0.5 mg/kg Imprime PGG administered over 1 hr
Single dose of 1.0 mg/kg Imprime PGG administered over 1 hr
Single dose of 2.0 mg/kg Imprime PGG administered over 1 hr
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
24 participants (actual enrollment reported by the registry).
First Submitted
October 10, 2007
First Posted
October 11, 2007
Study Start
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
Single dose of 4.0 mg/kg Imprime PGG administered over 2 hr
Single dose of 6.0 mg/kg Imprime PGG administered over 3 hr
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Study Completion
April 2006
Actual (reported)Last Updated
October 11, 2007
Record last verified: 2007-10
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Source: ClinicalTrials.gov.
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