A Phase 1 interventional study of Imprime PGG in Healthy, sponsored by HiberCell, Inc.. Completed. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-10-11.
Sponsored by HiberCell, Inc. · Phase 1 and Interventional
The purpose of this trial is to the assess the safety, pharmacodynamics, and pharmacokinetics of escalating doses of Imprime PGG™ 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:
HiberCell, Inc. is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single dose of 0.5 mg/kg Imprime PGG administered over 1 hr
Biological: Imprime PGG
Single dose of 1.0 mg/kg Imprime PGG administered over 1 hr
Biological: Imprime PGG
Single dose of 2.0 mg/kg Imprime PGG administered over 1 hr
Biological: Imprime PGG
Single dose of 4.0 mg/kg Imprime PGG administered over 2 hr
Biological: Imprime PGG
Single dose of 6.0 mg/kg Imprime PGG administered over 3 hr
Biological: Imprime PGG
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.
Time frame: 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)
Time frame: 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.
Time frame: Prospective
No study locations are listed for this record.
This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.
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HiberCell, Inc.