MP101 in Adults 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.

Inclusion Criteria: * 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 . Exclusion Criteria: * Persistent septic shock or hemodynamically unstable condition. * Active pulmonary tuberculosis or non-bacterial pneumonia. * Significant pleural effusion or lung abscess requiring therapeutic drainage. * Clinically significant cardiovascular, hepatic, or renal impairment . * Immunocompromised status or hematological malignancies. * Known hypersensitivity to bacteriophages, study components, or concomitant antibiotics. * Participation in another clinical trial within 30 days prior to screening. * Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for the study.