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

Sponsored by:	Biothera
Information provided by:	Biothera
ClinicalTrials.gov Identifier:	NCT00542464

Purpose

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.

Condition	Intervention	Phase
Healthy	Biological: Imprime PGG TM for Injection	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Multiple-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:

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). [ Time Frame: Prospective ]

Secondary Outcome Measures:

-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). [ Time Frame: 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. [ Time Frame: Prospective ]

Enrollment:	12
Study Start Date:	May 2006
Study Completion Date:	September 2006

Arms	Assigned Interventions
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 Doses of 1.0 mg/kg-4.0 mg/kg of Imprime PGG administered over 1-2 hr for 7 consecutive days
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 Doses of 1.0 mg/kg-4.0 mg/kg of Imprime PGG administered over 1-2 hr for 7 consecutive days
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 Doses of 1.0 mg/kg-4.0 mg/kg of Imprime PGG administered over 1-2 hr for 7 consecutive days

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 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

Exclusion Criteria:

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)
Have any clinical condition that, in the opinion of the principal investigator, warrants exclusion from the study from a scientific, procedural, or safety perspective

Contacts and Locations

No Contacts or Locations Provided

More Information

Study ID Numbers:	BIOBG-CL-002
Study First Received:	October 10, 2007
Last Updated:	October 10, 2007
ClinicalTrials.gov Identifier:	NCT00542464
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biothera:

Safety in Healthy Adult Subjects

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 15, 2009