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

NCT00542217 | Completed Phase 1 DMC

• 1 other identifier: BIOBG-CL-001
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy

Keywords

Healthy Volunteers

Outcome Measures

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.

  Prospective

Secondary Outcomes (2)

• -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

Study Arms (5)

Cohort 1

PLACEBO COMPARATOR

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

Biological: Imprime PGG

Cohort 2

PLACEBO COMPARATOR

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

Biological: Imprime PGG

Cohort 3

PLACEBO COMPARATOR

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

Biological: Imprime PGG

Cohort 4

PLACEBO COMPARATOR

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

Biological: Imprime PGG

Cohort 5

PLACEBO COMPARATOR

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

Biological: Imprime PGG

Interventions

Imprime PGG BIOLOGICAL

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 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
• Be healthy as determined by the investigator on the basis of medical history, the physical examination, electrocardiogram, and clinical laboratory test results
• 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
• Have provided written authorization for use and disclosure of protected health information

You may not qualify if:

• Have a known hypersensitivity to baker's yeast
• Have a history of tobacco use within 3 months of the Screening Period
• Be a known or suspected abuser of alcohol or other drugs of abuse
• Have an active yeast infection
• Have a positive hepatitis B, hepatitis C, or human immunodeficiency virus test during the Screening Period
• 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.)
• Have participated in an investigational drug study within 30 days or five half-lives (whichever is longer) of the Screening Period
• Have donated or lost more than a unit of blood within 30 days of the Screening Period

Sponsors & Collaborators

• HiberCell, Inc.: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 10, 2007
• First Posted: October 11, 2007
• Study Start: December 1, 2005
• Study Completion: April 1, 2006
• Last Updated: October 11, 2007

Record last verified: 2007-10