Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™)

Inclusion Criteria: * Written informed consent obtained from patient or designated legal guardian prior to the performance of any study related procedures. * Male or female study subjects ≥6 years of age or older * Confirmed diagnosis of CF * History of chronic infection with P. aeruginosa * Study subjects must produce a screening specimen that is positive for growth of P. aeruginosa * FEV1 ≥ 40% predicted at Screening * SaO2 ≥ 90% at Screening while breathing room air * Ability to comply with study medication use, study visits and study procedures as judged by the investigator * Ability to produce sputum or be willing to undergo an induction to produce sputum for clinical evaluation * Clinically stable with no evidence of acute upper or lower respiratory tract infection of history of pulmonary exacerbation within 4 weeks prior to screening Key Exclusion Criteria: * Administration of any investigational drug within 8 weeks prior to Screening * Emergency room visit or hospitalization for CF or respiratory-related illness within 4 weeks prior to screening * History of alcohol, medication or illicit drug abuse within the 1 year prior to screening * History of lung transplant * Female of childbearing potential who is lactating or is not practicing an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or IUD) * Positive pregnancy test * Use of any anti-pseudomonal anitbiotics (IV antibiotics, all inhalation antibiotics, ora…