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

This is a randomized, double-blind, placebo-controlled, single-dose, dose-escalation phase 1 study in adult patients with acute Pseudomonas aeruginosa pneumonia. Approximately 18 participants will be enrolled at about 6 study sites in Korea. Participants will be assigned to either a low-dose cohort or a high-dose cohort and will receive MP101 or matching placebo in addition to standard antibiotic therapy. Escalation to the high-dose cohort will occur after review of available safety data by the Safety Review Committee.

The study is designed to evaluate the safety and tolerability of MP101 and to characterize its pharmacokinetic and pharmacodynamic profile in blood and sputum. The study will also assess antibacterial activity against Pseudomonas aeruginosa, including changes in sputum bacterial burden and changes in susceptibility to MP101 and concomitant antibiotics. Additional exploratory assessments include inflammatory biomarkers and clinical outcome measures in patients with acute pneumonia.

After screening within 7 days before dosing, participants will receive study treatment on Day 1 and remain under inpatient observation through Day 8 for safety and PK/PD assessments. Follow-up visits will be conducted on Day 15 and Day 29. Study assessments include adverse events, clinical laboratory tests, vital signs, electrocardiograms, microbiologic evaluations in sputum, and protocol-defined exploratory assessments.