-  1. Unwilling or unable to give informed consent.<br/><br/>          -  2. As a result of the medical screening process, the study physician considers the<br/>             subject unfit for the study.<br/><br/>          -  3. Demonstrating excess in xanthine consumption (more than 5 cups of coffee or<br/>             equivalent per day).<br/><br/>          -  4. Subjects who smoke more than 10 cigarettes a day.<br/><br/>          -  5. Subjects who consume more than 28 units (males) or more than 21 units (females) of<br/>             alcohol per week.<br/><br/>          -  6. Any history of hypersensitivity to the IMP.<br/><br/>          -  7. For subjects with renal impairment: No clinically significant change in disease<br/>             status within at least 1 month prior to study entry, as determined by the<br/>             investigator.<br/><br/>          -  8. The subject had donated a unit of blood (450 mL) within the 3 months before<br/>             dosing, or intends to donate in the month after the last scheduled visit.<br/><br/>          -  9. Participation in another clinical study with an investigational drug or device<br/>             within the last month.<br/><br/>          -  10. Subjects with clinically significant telemetric ECG abnormalities on Day -1<br/><br/>          -  11. Significant allergies requiring intranasal or systemic corticosteroids during any<br/>             time of the year or history of any anaphylactic reaction.<br/><br/>          -  12. Positive test for human immunodeficiency virus (HIV) antibodies.<br/><br/>          -  13. Acute Hepatitis B or C infection.<br/><br/>          -  14. The subject has tested positive for drugs of abuse at screening.<br/><br/>          -  15. Subjects who have received any prescribed systemic or topical medication within 4<br/>             weeks prior to dosing (excluded are those drugs the renally impaired subject is<br/>             currently taking for treatment of the renal or concomitant disease).<br/><br/>          -  16. Immunocompromised patients (patients after solid organ or bone marrow transplant;<br/>             patients receiving immunosuppressive treatment).<br/><br/>          -  17. Subjects with known or suspected Pseudomonas infection or colonization (e.g.<br/>             patients with cystic fibrosis).<br/>