MP101 in Adults With Acute Pseudomonas Aeruginosa Pneumonia

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат 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
• Препарат 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.

Первичные конечные точки

• 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. [Срок оценки: Throughout the clinical trial period from screening through Day 29 (D29)]

Вторичные конечные точки (7)

• Maximum Observed Plasma Concentration (Cmax) of MP101 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: pre-dose, 120, 168, 336, and 672 hours (Day 29) post-dose.]
• Change From Baseline in Susceptibility of Pseudomonas Aeruginosa (PA) to Antibiotics [Срок оценки: pre-dose, 120, 168, 336, and 672 hours (Day 29) post-dose.]

Критерии участия

Критерии включения

• 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 .

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Severance Hospital — Seoul

Идентификаторы

NCT: NCT07492771 · MP101-1001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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