Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

healthy normal male and female subjects, ages 18 to 45, inclusive;
able to communicate and able to provide valid, written informed consent;
within the body mass index (BMI) range of approximately 18.0 to 30.0 kg/m2, inclusive;
minimum weight of 50 kg;
willingness to remain totally abstinent or use adequate contraception; e.g., 2 of the following methods: hormonal contraceptive, intrauterine device, condom, diaphragm, and spermicidal gel/foam) in order to prevent pregnancy from the screening visit until 60 days after the follow-up visit. For men, the donation of sperm during this period is also prohibited.

Exclusion Criteria:

the presence of clinically significant medical history as determined by the investigator.
the history of clinically significant cardiac abnormalities or presence of clinically significant abnormality on 12-lead ECG.
the history of pre-existing paresthesia or neuropathy;
abnormalities on neurologic exam at screening or baseline
the history of any cancer requiring systemic chemotherapy or radiation; individuals with a history of non-melanoma skin cancer, nonrecurring carcinoma in situ treated with laser or cryotherapy or cervical cancer-in-situ, resected surgically with no evidence of disease, may be accepted on a case by case basis at the discretion of the Investigator;
the presence of acute infection or history of acute infection within 7 days prior to receipt of the study drug; additionally, oral temperature may not exceed 37.4°C at baseline;
the presence of clinically significant laboratory abnormalities (chemistry panel of 20 analytes [Chem-20; fasted 10-12 hours], complete blood count [CBC], and urinalysis [UA]) as determined by the investigator;
positive urine drug screen for drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, cotinine, tricyclic antidepressants and alcohol) at Screening or at Baseline.
typical intake of more than 7 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
a positive hepatitis screen (Hepatitis BsAg or anti-HCV) or positive Human Immunodeficiency Virus (HIV) antibody test ;
a history of multiple drug allergies that are important in the view of the Investigator;
any history of anaphylaxis or a history of allergy to a medication, diet, or environmental exposure (including bee stings) that are important in the view of the Investigator;
participation in another clinical trial with receipt of an investigational product within 60 days of dose administration (or 5 half lives, whichever is longer);
recent (within 1 year of Screening) history of illicit drug use;
history of alcohol abuse that is important in the view of the Investigator
inadequate venous access that would interfere with obtaining blood samples;
use of prescription medications, over the counter products, herbal remedies and nutritional supplements within 7 days of study drug administration and throughout the study, or the anticipated need for prescription medications prior to Study Completion;
recipients of blood transfusion or transfusion of blood or plasma products within 60 days of study drug administration;
donation of blood > 500 mL within 2 months of study drug administration;
positive pregnancy test at screening or at baseline (female subjects only);
history within the past 3 months of eating disorders or other conditions which may lead to suspicion about the participant's nutritional status;
inability or unwillingness to comply with study restrictions