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NOT YET RECRUITING
NCT07492771
PHASE1

MP101 in Adults With Acute Pseudomonas Aeruginosa Pneumonia

Sponsor: MicrobiotiX Co., Ltd

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-03

Completion Date

2026-12

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

BIOLOGICAL

MP101

This clinical trial is a Phase 1 study with a randomized, double-blind, placebo-controlled, single-dose, sequential dose-escalation design and consists of two dose cohorts. After the safety of the low-dose cohort (Cohort A) is evaluated, dosing will proceed to the high-dose cohort (Cohort B). The investigational product, MP101, is a cocktail formulation comprising two bacteriophages. Participants in Cohort A will receive low dose, and participants in Cohort B will receive high dose. MP101 will be administered as a single intravenous infusion. The placebo is a clear solution with the same appearance as MP101 but without bacteriophages, and it will be administered in the same manner.

DRUG

Antibiotics

All study subjects will receive concomitant antibiotic therapy. The choice of the concomitant antibiotic will be based on the results of antibiotic susceptibility testing and will follow the best available therapy, as determined by the investigator.

Locations (1)

Severance Hospital

Seoul, Seodaemun-gu, South Korea