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

NCT00542464 | Completed Phase 1 DMC

• 1 other identifier: BIOBG-CL-002
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Keywords

Safety in Healthy Adult Subjects

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• -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

Study Arms (3)

Cohort 1

PLACEBO COMPARATOR

1.0 mg/kg Imprime PGG administered daily over 1 hr for 7 consecutive days

Biological: Imprime PGG TM for Injection

Cohort 2

PLACEBO COMPARATOR

2.0 mg/kg Imprime PGG administered daily over 1 hr for 7 consecutive days

Biological: Imprime PGG TM for Injection

Cohort 3

PLACEBO COMPARATOR

4.0 mg/kg Imprime PGG administered daily over 2 hr for 7 consecutive days

Biological: Imprime PGG TM for Injection

Interventions

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

Cohort 1; Cohort 2; Cohort 3

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 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• HiberCell, Inc.: lead

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

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: May 1, 2006
• Study Completion: September 1, 2006
• Last Updated: October 11, 2007

Record last verified: 2007-10