A Phase 1 interventional study of MP101 and Antibiotics in Pneumonia - Bacterial and Pseudomonas Aeruginosa Infection, sponsored by MicrobiotiX Co., Ltd. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by MicrobiotiX Co., Ltd · Phase 1, Interventional, and Treatment
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.
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.
153 studies on the registry are indexed under Pneumonia, Bacterial; 27 are open to participants now.
This study's planned enrollment of 18 is below the median of 132 across 107 interventional studies indexed under Pneumonia, Bacterial.
Browse Pneumonia, Bacterial studies →This is the only study on the registry with MicrobiotiX Co., Ltd as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Participants in the placebo group will receive a single intravenous infusion of placebo in addition to standard antibiotic therapy.
Drug: Antibiotics
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.
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
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)
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.
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.
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.
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.
Antibacterial Activity of MP101 Against Pseudomonas aeruginosa (PA) in Sputum
Assessment of the change in bacterial load of Pseudomonas aeruginosa in sputum samples.
Time frame: 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).
Time frame: 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)
Time frame: pre-dose, 120, 168, 336, and 672 hours (Day 29) post-dose.
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 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.
Time frame: 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).
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.
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 29
Plan to share: No — There is no current plan to provide access to individual participant data to other researchers.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: MP-101