A Study to Assess the Pharmacokinetic Profile, the Safety, and the Tolerability of ME1100 Inhalation Solution in Patients With Mechanically Ventilated Bacterial Pneumonia

Exclusion Criteria

• •1. Has a requirement of inhaled non-study antibiotic;
• •2. Has been treated with any inhaled antibiotic (including inhaled aminoglycosides) within 72 hours of study entry;
• •3. Has renal insufficiency at Screening as evidenced by an estimated creatinine clearance \<50 mL/min based on the Cockcroft-Gault formula;
• •4. Is at risk of rapidly fatal illness and death within the next 72 hours;
• •5. Is a pregnant or nursing female. Females of childbearing potential must have a serum pregnancy test prior to enrollment. If results of the serum pregnancy test are not available prior to the Day 1 Treatment Visit, the patients may be enrolled on the basis of a negative urine pregnancy test; however, the results of the serum pregnancy test must still be obtained. If either test is positive, the patients must be excluded;
• •6. Has myasthenia gravis, parkinsonism, or any other progressive neuromuscular disorder;
• •7. Has a history of epilepsy or known seizure disorder;
• •8. Has a history of sensorineural hearing loss resulting from any therapy known as ototoxic (eg, aminoglycosides, cisplatin, loop diuretics, or quinine);
• •9. Has received any investigational medication in the last 30 days (or 5 half-lives of the investigational medication, whichever is longer) prior to the Screening Visit; or
• •10. Has known hypersensitivity to ME1100, aminoglycosides, or any of the specified Best Available Therapy agents or their excipients.