|Exclusion Criteria:||1) New York Heart Association (NYHA) Class III or IV, cardiac disease, myocardial infarction within 6 months prior to Day 1, or unstable arrhythmia.|
2) Uncontrolled seizure disorder.
3) Severe chronic obstructive pulmonary disease with hypoxemia or in the opinion of the investigator any physiological state leading to hypoxemia.
4) Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery.
5) Active uncontrolled infections.
6) Systemic chemotherapy (with the exception of hydroxyurea and/or steroids) within 14 days (within 5 half-lives for an investigational agent) prior to first dose of study drug, unless there is evidence of rapidly progressive disease. Concurrent therapy for CNS prophylaxis or continuation of therapy for controlled CNS disease is permitted.
7) Known active infection with HIV, hepatitis B, or hepatitis C.
8) Patients who have exhibited allergic reactions to a structural compound similar to TH-302 or its excipients.
9) Females who are pregnant or breast-feeding.
10) Unwillingness or inability to comply with the study protocol for any reason.
11) Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study