CClinicalTrials.gg
CompletedNCT00542217Updated Oct 11, 2007

Phase Ia Dose-Escalation Safety, Pharmacodynamic and Pharmacokinetic Study of Imprime PGG™ Injection

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

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The purpose of this trial is to the assess the safety, pharmacodynamics, and pharmacokinetics of escalating doses of Imprime PGG™ Injection in healthy volunteers.

Read the detailed description

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:

  1. to determine the pharmacodynamics of a single intravenous dose of Imprime PGG when administered to healthy adult subjects by assessing the number of subjects who experience a 15% or more increase from baseline in the percentage of neutrophils with primed CR3; and
  2. 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.
02

Conditions studied

  • Healthy

Keywords

  • Healthy Volunteers
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Have a known hypersensitivity to baker's yeast
  2. Have a history of tobacco use within 3 months of the Screening Period
  3. Be a known or suspected abuser of alcohol or other drugs of abuse
  4. Have an active yeast infection
  5. Have a positive hepatitis B, hepatitis C, or human immunodeficiency virus test during the Screening Period
  6. Except as otherwise indicated, have taken any prescription medication within 14 days of study drug administration on Day 0 or over-the-counter medication, herbal preparation, or vitamins within 1 week of study drug administration on Day 0 (The following medications are exempted from this criterion: acetaminophen [maximum 3 g/day], female hormone replacement therapy, and oral contraceptives.)
  7. Have participated in an investigational drug study within 30 days or five half-lives (whichever is longer) of the Screening Period
  8. Have donated or lost more than a unit of blood within 30 days of the Screening Period
  9. Have any clinical condition that, in the opinion of the principal investigator, warrants exclusion from the study for either a scientific, procedural, or safety perspective
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Placebo comparator
    Cohort 1

    Single dose of 0.5 mg/kg Imprime PGG administered over 1 hr

    Biological: Imprime PGG

  • Placebo comparator
    Cohort 2

    Single dose of 1.0 mg/kg Imprime PGG administered over 1 hr

    Biological: Imprime PGG

  • Placebo comparator
    Cohort 3

    Single dose of 2.0 mg/kg Imprime PGG administered over 1 hr

    Biological: Imprime PGG

  • Placebo comparator
    Cohort 4

    Single dose of 4.0 mg/kg Imprime PGG administered over 2 hr

    Biological: Imprime PGG

  • Placebo comparator
    Cohort 5

    Single dose of 6.0 mg/kg Imprime PGG administered over 3 hr

    Biological: Imprime PGG

Interventions

  • BiologicalImprime PGG
06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. -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

  2. 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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00542217
Lead sponsor
HiberCell, Inc.
First posted
Oct 11, 2007
Start date
Dec 2005
Completion
Apr 2006
Last update
Oct 11, 2007

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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