MP101 in Adults With Acute Pseudomonas Aeruginosa Pneumonia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorMicrobiotiX Co., Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Persistent septic shock or hemodynamically unstable condition.
Active pulmonary tuberculosis or non-bacterial pneumonia.
Significant pleural effusion or lung abscess requiring therapeutic drainage.
Clinically significant cardiovascular, hepatic, or renal impairment .
Trial design
Design model
Parallel
Treatments tested in this trial
MP101
Biological/VaccineThis 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.
Antibiotics
DrugAll 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.
Treatment groups
18 Participants
are divided into 3 treatment groupsGroup A: Low-dose cohort (Cohort A)Experimental treatment 2 interventions
Group B: High-dose cohort (Cohort B)Experimental treatment 2 interventions
Group C: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Throughout the clinical trial period from screening through Day 29 (D29)Secondary outcomes
1
Maximum Observed Plasma Concentration (Cmax) of MP101
The maximum concentration of MP101 in plasma observed after administration.
Time frame
Pre-dose, 15 min, 30 min, 1, 2, 4, 8, 24, 48, 72, 96, 120, 168, 336, and 672 hours (Day 29) post-dose.2
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.
Time frame
Pre-dose, 15 min, 30 min, 1, 2, 4, 8, 24, 48, 72, 96, 120, 168, 336, and 672 hours (Day 29) post-dose.3
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.
Time frame
Pre-dose, 15 min, 30 min, 1, 2, 4, 8, 24, 48, 72, 96, 120, 168, 336, and 672 hours (Day 29) post-dose.4
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.
Time frame
Pre-dose, 15 min, 30 min, 1, 2, 4, 8, 24, 48, 72, 96, 120, 168, 336, and 672 hours (Day 29) post-dose.Other outcomes
1
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.
Time frame
Up to Day 292
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.
Time frame
Up to Day 293
Retrospective Pharmacokinetic (PK) Evaluation of MP101
Retrospective analysis of MP101 pharmacokinetic parameters in blood samples using quantitative Polymerase Chain Reaction (qPCR).
Time frame
Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 24, 48, 72, 96, 120, 168, 336, and 672 hours (Day 29) post-dose.4
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.
Time frame
Baseline (Pre-dose) and Day 29Sponsors and contacts
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Source ClinicalTrials.gov