Study to Evaluate Whether BLI-489 Can be Safely Tolerated by Healthy Subjects Given Multiple Doses

Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of BLI-489 Administered Intravenously to Healthy Subjects

To determine the safety, tolerability, and drug absorption profile of multiple IV doses of BLI 489 in healthy subjects.

Inclusion Criteria:

• Men or women of non-childbearing potential (WONCBP) aged 18 to 50 years inclusive at screening;
• Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight ≥50 kg.;
• Healthy as determined by the investigator on the basis of screening evaluations;
• Calculated creatinine clearance within normal limits using the Cockcroft-Gault formula;
• Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history, and if a smoker must be able to abstain from smoking during the inpatient stay;
• Have a high probability for compliance with and completion of the study.

Exclusion Criteria:

• Presence or history of any disorder that may prevent the successful completion of the study;
• Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease;
• Any surgical or medical condition that may interfere with the distribution, metabolism, or excretion of the investigational product;
• Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1;
• History of drug abuse within 1 year before study day 1;
• Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements.