A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of MP101 in Adult Patients With Acute Pseudomonas Aeruginosa Pneumonia
The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of MP101 administered in addition to standard antibiotic therapy in adult patients with acute Pseudomonas aeruginosa pneumonia. The study will also assess the pharmacokinetic and pharmacodynamic characteristics of MP101 and its antibacterial activity, including changes in P. aeruginosa burden in sputum and changes in susceptibility to MP101 and concomitant antibiotics.
• Subjects aged 19 years or older.
• Clinical diagnosis of acute pneumonia with radiologic evidence of pulmonary infiltrates.
• Confirmed Pseudomonas aeruginosa (PA) infection via valid respiratory specimens.
• PA isolate demonstrates susceptibility to MP101 and non-susceptibility to current antibiotic therapy.
• Adequate organ function as defined by hematological, hepatic, and renal laboratory parameters .