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

Purpose

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

Condition	Intervention	Phase
Healthy	Biological: Imprime PGG	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title:	Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Safety, Pharmacodynamics, and Pharmacokinetics Study of Intravenous Imprime PGG™ Injection in Healthy Adult Subjects

Further study details as provided by Biothera:

Primary Outcome Measures:

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 Outcome Measures:

-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 ]
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 ]

Enrollment:	24
Study Start Date:	December 2005
Study Completion Date:	April 2006

Arms	Assigned Interventions
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

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:

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
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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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 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

Exclusion Criteria:

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
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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00542217 History of Changes
Other Study ID Numbers:	BIOBG-CL-001
Study First Received:	October 10, 2007
Last Updated:	October 10, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biothera:

Healthy Volunteers

ClinicalTrials.gov processed this record on May 19, 2013