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

HiberCell

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Biological: Imprime PGG TM for Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT00542464

BIOBG-CL-002

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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