A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Safety, Pharmacodynamics, and Pharmacokinetics Study of Intravenous Imprime PGG™ Injection in Healthy Adult Subjects
Sponsor study identifier
interventional
12
0 countries
N/A
Study Start
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
September 2006
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
September 2006
Actual (reported)October 10, 2007
Actual (reported)October 11, 2007
Actual (reported)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
-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
1.0 mg/kg Imprime PGG administered daily over 1 hr for 7 consecutive days
2.0 mg/kg Imprime PGG administered daily over 1 hr for 7 consecutive days
4.0 mg/kg Imprime PGG administered daily over 2 hr for 7 consecutive days
Doses of 1.0 mg/kg-4.0 mg/kg of Imprime PGG administered over 1-2 hr for 7 consecutive days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
12 participants (actual enrollment reported by the registry).
First Submitted
October 10, 2007
First Posted
October 11, 2007
Study Start
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Study Completion
September 2006
Actual (reported)Last Updated
October 11, 2007
Record last verified: 2007-10
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Source: ClinicalTrials.gov.
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