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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: Imprime PGG TM for Injection

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 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
4. Be healthy as determined by the investigator on the basis of medical history, physical examination, electrocardiogram, and clinical laboratory test results
5. 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
6. Have provided written authorization for use and disclosure of protected health information

Exclusion Criteria:

1. Have a known hypersensitivity to baker's yeast
2. Have a history of tobacco use within 3 months of first day of screening
3. Be a known or suspected abuser of alcohol or other drugs/substances of abuse at anytime
4. Have an active yeast infection
5. Have a positive hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) test conducted as part of screening
6. 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
7. 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
8. Have donated or lost more than a unit of blood within 30 days of the last day of screening (Day -1)
9. Have any clinical condition that, in the opinion of the principal investigator, warrants exclusion from the study from a scientific, procedural, or safety perspective

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Cohort 1; 1.0 mg/kg Imprime PGG administered daily over 1 hr for 7 consecutive days	Biological: Imprime PGG TM for Injection; Doses of 1.0 mg/kg-4.0 mg/kg of Imprime PGG administered over 1-2 hr for 7 consecutive days
PLACEBO_COMPARATOR: Cohort 2; 2.0 mg/kg Imprime PGG administered daily over 1 hr for 7 consecutive days	Biological: Imprime PGG TM for Injection; Doses of 1.0 mg/kg-4.0 mg/kg of Imprime PGG administered over 1-2 hr for 7 consecutive days
PLACEBO_COMPARATOR: Cohort 3; 4.0 mg/kg Imprime PGG administered daily over 2 hr for 7 consecutive days	Biological: Imprime PGG TM for Injection; Doses of 1.0 mg/kg-4.0 mg/kg of Imprime PGG administered over 1-2 hr for 7 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
-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

Collaborators and Investigators

• Sponsor: HiberCell, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Study Completion (ACTUAL): September 1, 2006

Study Registration Dates

• First Submitted: October 10, 2007
• First Submitted That Met QC Criteria: October 10, 2007
• First Posted (ESTIMATE): October 11, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): October 11, 2007
• Last Update Submitted That Met QC Criteria: October 10, 2007
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Keywords: Safety in Healthy Adult Subjects
• Other Study ID Numbers: BIOBG-CL-002