MP101 in Adults With Acute Pseudomonas Aeruginosa Pneumonia (MP101-1001)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pseudomonas Aeruginosa Infection; Pneumonia - Bacterial
• Intervention / Treatment: Biological: MP101; Drug: Antibiotics

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sangmin Lee, Director; Phone Number: 82-10-2807-7489; Email: smlee@microbiotix.net

Study Locations

• South Korea
  • Seodaemun-gu
    • Seoul, Seodaemun-gu, South Korea, 03722
      • Severance Hospital
      • Contact: Jun Yong Choi, Professor; Phone Number: 82-2-2228-1974; Email: seran@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 suspected non-bacterial pneumonia.
• Significant pleural effusion or lung abscess requiring therapeutic drainage.
• Clinically significant cardiovascular, hepatic, or renal impairment .
• Immunocompromised status or history of 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-dose cohort (Cohort A); Participants in the low-dose cohort (Cohort A) will receive a single intravenous infusion of MP101 in addition to standard antibiotic therapy.	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.; Other Names: Standard antibiotic therapy
Experimental: High-dose cohort (Cohort B); Participants in the high-dose cohort (Cohort B) will receive a single intravenous infusion of MP101 in addition to standard antibiotic therapy.	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.; Other Names: Standard antibiotic therapy
Placebo Comparator: Placebo group; Participants in the placebo group will receive a single intravenous infusion of placebo in addition to standard antibiotic therapy.	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.; Other Names: Standard antibiotic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and frequency of adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs), and serious adverse drug reactions (SADRs) occurring after administration of MP101.	Throughout the clinical trial period from screening through Day 29 (D29)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of MP101	The maximum concentration of MP101 in plasma observed after administration.	Pre-dose, 15 min, 30 min, 1, 2, 4, 8, 24, 48, 72, 96, 120, 168, 336, and 672 hours (Day 29) post-dose.
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast)	The area under the plasma concentration-versus-time curve from time 0 to the last time point with a measurable concentration.	Pre-dose, 15 min, 30 min, 1, 2, 4, 8, 24, 48, 72, 96, 120, 168, 336, and 672 hours (Day 29) post-dose.
Terminal Elimination Half-life (t1/2) of MP101	The time required for the plasma concentration of MP101 to decrease by 50% during the terminal elimination phase.	Pre-dose, 15 min, 30 min, 1, 2, 4, 8, 24, 48, 72, 96, 120, 168, 336, and 672 hours (Day 29) post-dose.
Apparent Volume of Distribution (Vz) of MP101	The theoretical volume that would be necessary to contain the total amount of an administered drug at the same concentration that it is observed in the blood plasma.	Pre-dose, 15 min, 30 min, 1, 2, 4, 8, 24, 48, 72, 96, 120, 168, 336, and 672 hours (Day 29) post-dose.
Antibacterial Activity of MP101 Against Pseudomonas aeruginosa (PA) in Sputum	Assessment of the change in bacterial load of Pseudomonas aeruginosa in sputum samples.	pre-dose, 4, 8, 24, 48, 72, 96, 120, 168, 336, and 672 hours (Day 29) post-dose.
Change From Baseline in Susceptibility of Pseudomonas Aeruginosa (PA) to MP101	Evaluation of the change from baseline in the susceptibility of Pseudomonas aeruginosa (PA) isolated from sputum samples to MP101, measured by Phage Susceptibility Testing (PST).	pre-dose, 120, 168, 336, and 672 hours (Day 29) post-dose.
Change From Baseline in Susceptibility of Pseudomonas Aeruginosa (PA) to Antibiotics	Evaluation of the change from baseline in the susceptibility of Pseudomonas aeruginosa (PA) isolated from sputum samples to concomitant antibiotics, measured by Antimicrobial Susceptibility Testing (AST)	pre-dose, 120, 168, 336, and 672 hours (Day 29) post-dose.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Prognosis of Acute Pneumonia	valuation of clinical outcomes including the proportion and duration of new ventilator use, organ failure occurrence, improvement of respiratory symptoms, and changes in antibiotic use.	Up to Day 29
Retrospective Pharmacokinetic (PK) Evaluation of MP101	Retrospective analysis of MP101 pharmacokinetic parameters in blood samples using quantitative Polymerase Chain Reaction (qPCR).	Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 24, 48, 72, 96, 120, 168, 336, and 672 hours (Day 29) post-dose.
Analysis of Pseudomonas aeruginosa (PA) Genetic Profile	Analysis of Whole Genome Sequencing (WGS) and mutation analysis from baseline in Pseudomonas aeruginosa (PA) isolated from sputum samples to evaluate genetic changes following MP101 administration.	Baseline (Pre-dose) and Day 29
Changes in Serum Levels of Inflammatory Markers (ESR, CRP, Procalcitonin) and Cytokines (IL-1β, IL-6, TNF-α)	Assessment of the change from baseline in physiological inflammatory parameters, including Erythrocyte Sedimentation Rate (ESR), C-Reactive Protein (CRP), procalcitonin, and inflammatory cytokines (Interleukin-1 beta [IL-1β], Interleukin-6 [IL-6], and Tumor Necrosis Factor-alpha [TNF-α]), measured via laboratory blood analysis.	Up to Day 29

Collaborators and Investigators

• Sponsor: MicrobiotiX Co., Ltd
• Investigators: Principal Investigator: Jun Yong Choi, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Acute Pseudomonas Aeruginosa Pneumonia
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Pseudomonas Infections; Pneumonia, Bacterial; Anti-Infective Agents; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Anti-Bacterial Agents
• Other Study ID Numbers: MP101-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no current plan to provide access to individual participant data to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No