Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis

Key Inclusion Criteria: * ≥ 18 years old * Body mass index (BMI) of ≥ 18 kg/m2 * Documented diagnosis of CF * Evidence of chronic pulmonary Pseudomonas aeruginosa infection * Willing to undergo sputum induction procedures at designated study visits, and willing to provide expectorated sputum samples at all other timepoints (for subjects who are able to expectorate) * For SAD: FEV1 ≥ 60% of predicted normal \[per Global Lung Function Initiative (GLI) standards\] at Screening * For MAD: FEV1 ≥ 40% of predicted normal \[per Global Lung Function Initiative (GLI) standards\] at Screening * Adequate renal function Key Exclusion Criteria: * Recent significant weight loss * Abnormal vital signs at Screening * History of prolonged QT syndrome * Use of supplemental oxygen during the day at rest * Abnormal liver function tests greater than 3X the upper limit of normal (ULN) * Recent oral or IV antibiotics received for acute pulmonary exacerbation. Inhaled antibiotic use for chronic suppression of P. aeruginosa is acceptable. * Recent clinically significant infection requiring systemic antimicrobial therapy * Currently receiving anti-pseudomonal antibiotic treatment for acute sinusitis. * Currently receiving systemic corticosteroids * Currently receiving treatment for active infection with nontuberculous mycobacteria (NTM), Staphylococcus aureus, or Burkholderia cepacia complex lung infection * Currently receiving treatment for aspergillosis or ABPA (allergic bronchopulmonary aspergil…