Clinical Drug Experience Knowledgebase

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