Multiple-Dose, Dose-Escalation Safety, Pharmacodynamics, and Pharmacokinetics Study of Imprime PGG™ Injection

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Be aged 18 to 45 years, inclusive
Have a body weight of 45 to 125 kg, inclusive, and a body mass index less than or equal to 30 kg/m2
If female, be non-pregnant and non-nursing, and if pre-menopausal, have a negative serum pregnancy test confirmed prior to enrollment and practicing at least two methods of birth control
Be healthy as determined by the investigator on the basis of medical history, physical examination, electrocardiogram, and clinical laboratory test results
Have the ability to understand the requirements of the study, provide written informed consent, and agree to abide by the study restrictions and to return for the required assessments
Have provided written authorization for use and disclosure of protected health information

Exclusion criteria

Have a known hypersensitivity to baker's yeast
Have a history of tobacco use within 3 months of first day of screening
Be a known or suspected abuser of alcohol or other drugs/substances of abuse at anytime
Have an active yeast infection
Have a positive hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) test conducted as part of screening
Except as otherwise indicated, have taken any prescription medication within 30 days of the last day of screening (Day -1) or over-the-counter medication, herbal preparation, or vitamins within 7 days of the last day of screening (Day -1); the following medications are exempted from this criterion: acetaminophen [maximum 3 g/day], female hormone replacement therapy, and oral contraceptives
Have participated in an investigational drug study within 30 days or five half lives (whichever is longer) of the last day of screening (Day -1) or have ever participated in a study with Imprime PGG or Betafectin
Have donated or lost more than a unit of blood within 30 days of the last day of screening (Day -1)
Have any clinical condition that, in the opinion of the principal investigator, warrants exclusion from the study from a scientific, procedural, or safety perspective

Treatment and study plan

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

Primary outcomes

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).

Time frame: Prospective

Secondary outcomes

-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).

Time frame: 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.

Time frame: Prospective

Sponsors and collaborators

Lead sponsor

HiberCell, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Safety, Pharmacodynamics, and Pharmacokinetics Study of Intravenous Imprime PGG™ Injection in Healthy Adult Subjects

Important dates

Study start: 2006
Study completion: 2006
First posted: Oct 11, 2007
Registry last updated: Oct 11, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed