MP101 in Adults With Acute Pseudomonas Aeruginosa Pneumonia

NCT07492771 | Not Yet Recruiting Phase 1

• 1 other identifier: MP101-1001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pneumonia - Bacterial; Pseudomonas Aeruginosa Infection

Keywords

Acute Pseudomonas Aeruginosa Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Maximum Observed Plasma Concentration (Cmax) of MP101

  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)

  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

  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

  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

  pre-dose, 4, 8, 24, 48, 72, 96, 120, 168, 336, and 672 hours (Day 29) post-dose.

Other Outcomes (4)

• Clinical Prognosis of Acute Pneumonia

  Up to Day 29

• Changes in Serum Levels of Inflammatory Markers (ESR, CRP, Procalcitonin) and Cytokines (IL-1β, IL-6, TNF-α)

  Up to Day 29

• Retrospective Pharmacokinetic (PK) Evaluation of MP101

  Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 24, 48, 72, 96, 120, 168, 336, and 672 hours (Day 29) post-dose.

Study Arms (3)

Low-dose cohort (Cohort A)

EXPERIMENTAL

Participants in the low-dose cohort (Cohort A) will receive a single intravenous infusion of MP101 in addition to standard antibiotic therapy.

Biological: MP101; Drug: Antibiotics

High-dose cohort (Cohort B)

EXPERIMENTAL

Participants in the high-dose cohort (Cohort B) will receive a single intravenous infusion of MP101 in addition to standard antibiotic therapy.

Biological: MP101; Drug: Antibiotics

Placebo group

PLACEBO COMPARATOR

Participants in the placebo group will receive a single intravenous infusion of placebo in addition to standard antibiotic therapy.

Drug: Antibiotics

Interventions

MP101 BIOLOGICAL

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.

High-dose cohort (Cohort B); Low-dose cohort (Cohort A)

Antibiotics DRUG

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.

Also known as: Standard antibiotic therapy

High-dose cohort (Cohort B); Low-dose cohort (Cohort A); Placebo group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• MicrobiotiX Co., Ltd: lead

Study Sites (1)

Severance Hospital

Seoul, Seodaemun-gu, 03722, South Korea

Location

MeSH Terms

Conditions

Pneumonia, Bacterial; Pseudomonas Infections

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Gram-Negative Bacterial Infections

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Jun Yong Choi

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sangmin Lee, Director

CONTACT

82-10-2807-7489; smlee@microbiotix.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 25, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)