Actively Recruiting
Phase 1 Randomized Study to Test Safety and Effects of MP101 with Antibiotics in Adults Having Acute Pseudomonas Aeruginosa Pneumonia
Led by MicrobiotiX Co., Ltd · Updated on 2026-07-28
18
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of a single intravenous dose of MP101 in adult patients with acute Pseudomonas aeruginosa pneumonia. This randomized, double-blind, placebo-controlled, phase 1 study also aims to understand how MP101 behaves in the body and its antibacterial effects, including changes in bacterial presence and susceptibility in sputum. The trial involves adult patients confirmed to have this specific bacterial pneumonia. Participants will be assigned to either a low-dose or a high-dose group receiving MP101 or a placebo, all in addition to standard antibiotic therapy. MP101 is administered as a single intravenous infusion, with dose escalation to the higher group after safety review. The placebo looks identical and is given the same way. Antibiotic choice is personalized based on susceptibility tests and best available therapy. After screening within 7 days before dosing, participants receive the study treatment on Day 1 and stay in the hospital for observation until Day 8 for safety and drug monitoring. Follow-up visits occur on Day 15 and Day 29. Assessments include monitoring side effects, lab tests, vital signs, ECGs, sputum microbiology, and exploratory evaluations of inflammatory markers and clinical outcomes.
CONDITIONS
Brief Title
MP101 in Adults With Acute Pseudomonas Aeruginosa Pneumonia
Research Team
S
Sangmin Lee, Director
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