Pneumonia - BacterialPhase 1MP101-1001NCT07492771
MP101 in Adults With Acute Pseudomonas Aeruginosa Pneumonia
A Phase 1 study testing MP101 and Antibiotics in people with Pneumonia - Bacterial and Pseudomonas Aeruginosa Infection, run by MicrobiotiX Co., Ltd at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pneumonia - Bacterial, Pseudomonas Aeruginosa Infection
- What is being tested?
- MP101 and Antibiotics
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jul 2026to Dec 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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 .
- Immunocompromised status or 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, Seodaemun-gu, 03722
Jun Yong Choi, Professor, 82-2-2228-1974, seran@yuhs.ac
About this study
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
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.
Read the 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.
- Being tested
- MP101, Antibiotics
- Keywords
- Acute Pseudomonas Aeruginosa Pneumonia
- Medical subject headings
- Pneumonia, Bacterial, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MP101Biological
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.
AntibioticsDrug
Also called Standard antibiotic therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout the clinical trial period from screening through Day 29 (D29)
Secondary outcomes (7)
Maximum Observed Plasma Concentration (Cmax) of MP101
The maximum concentration of MP101 in plasma observed after administration.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: pre-dose, 120, 168, 336, and 672 hours (Day 29) post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start25 Jul 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia - BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MicrobiotiX Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun Yong Choi, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492771
- Sponsor's protocol ID
- MP101-1001
- Acronym
- MP101-1001
- Status last verified
- Jul 2026
- First submitted
- 13 Mar 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to provide access to individual participant data to other researchers.