Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin

Exclusion Criteria

• •1. Known chronic medical conditions, including any respiratory condition such as asthma or chronic obstructive pulmonary disease, or cardiovascular conditions such as hypertension or coronary artery disease;
• •2. Prolongation of corrected QT interval (QTcB) at rest, where the mean QTcB interval is \>500 msec based on triplicate ECG at Screening;
• •3. Use of tobacco products within 6 months of Screening;
• •4. Women who are pregnant or breastfeeding;
• •5. Receipt of any investigational medication during the last month (30 days or 5 half-lives, whichever is longer) prior to enrollment;
• •6. Prior exposure to finafloxacin;
• •7. Use of any concomitant medication (including over-the-counter drugs, vitamins, and antacids) within 7 days prior to study drug administration and during the study (acetaminophen is allowed);
• •8. Any disorder that may interfere with the evaluation of study drug;
• •9. Known hypersensitivity to finafloxacin or to any other fluoroquinolone;
• •10. Donated any blood, plasma, or platelets in the 3 months prior to enrollment or on more than 2 occasions within the 12 months preceding the first dose of study drug;
• •11. Known history of tendon rupture or tendonitis;
• •12. A positive urine drug screen or breath alcohol test result at Screening or enrollment;
• •13. Known to have viral hepatitis, or are positive for the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody, or are positive for Human Immunodeficiency Virus (HIV) antibodies;
• •14. Clinically significant abnormal laboratory values at Screening or enrollment;
• •15. Unable or unwilling, in the judgment of the Investigator, to comply with the protocol;
• •16. An employee of the Investigator or study site with direct involvement in the proposed study or other studies under the direction of the Investigator or study site, or a family member of the site employee or the Investigator.