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

This study has been completed.
Sponsor:
Information provided by:
Biothera
ClinicalTrials.gov Identifier:
NCT00542217
First received: October 10, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  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:

  1. 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
  2. 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:

  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 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
  4. Be healthy as determined by the investigator on the basis of medical history, the physical examination, electrocardiogram, and clinical laboratory test results
  5. 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
  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 the Screening Period
  3. Be a known or suspected abuser of alcohol or other drugs of abuse
  4. Have an active yeast infection
  5. Have a positive hepatitis B, hepatitis C, or human immunodeficiency virus test during the Screening Period
  6. 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.)
  7. Have participated in an investigational drug study within 30 days or five half-lives (whichever is longer) of the Screening Period
  8. Have donated or lost more than a unit of blood within 30 days of the Screening Period
  9. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014