IA Trial Radar | ||
|---|---|---|
O estudo clínico NCT07492771 (MP101-1001) para Pneumonia Bacteriana, Infecção por Pseudomonas aeruginosa está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
Um estudo corresponde aos critérios do filtro
Visualização em cartões
MP101 in Adults With Acute Pseudomonas Aeruginosa Pneumonia (MP101-1001) Fase I 18
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07492771 (MP101-1001) vai avaliar tratamento para Pneumonia Bacteriana, Infecção por Pseudomonas aeruginosa. Este é um estudo intervencionista de Fase I. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 1 de março de 2026, com o objetivo de incluir 18 participantes. Coordenado por MicrobiotiX Co., Ltd e deve ser concluído em 1 de dezembro de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 25 de março de 2026.
Resumo
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 sus...Mostrar mais
Descrição detalhada
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 ...Mostrar mais
Título oficial
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
Condições médicas
Pneumonia BacterianaInfecção por Pseudomonas aeruginosaOutros IDs do estudo
- MP101-1001
Número NCT
Data de início (real)
2026-03
Última atualização postada
2026-03-25
Data de conclusão (estimada)
2026-12
Inscrição (estimada)
18
Tipo de estudo
Intervencionista
FASE
Fase I
Status
Ainda não recrutando
Palavras-chave
Acute Pseudomonas Aeruginosa Pneumonia
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Triplo-cego
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalLow-dose cohort (Cohort A) Participants in the low-dose cohort (Cohort A) will receive a single intravenous infusion of MP101 in addition to standard antibiotic therapy. | 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 re...Mostrar mais Antibióticos 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. |
ExperimentalHigh-dose cohort (Cohort B) Participants in the high-dose cohort (Cohort B) will receive a single intravenous infusion of MP101 in addition to standard antibiotic therapy. | 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 re...Mostrar mais Antibióticos 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. |
Comparador placeboPlacebo group Participants in the placebo group will receive a single intravenous infusion of placebo in addition to standard antibiotic therapy. | Antibióticos 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. |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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) |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Maximum Observed Plasma Concentration (Cmax) of MP101 | The maximum concentration of MP101 in plasma observed after administration. | 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. | 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. | 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. | 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. | 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). | 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) | pre-dose, 120, 168, 336, and 672 hours (Day 29) post-dose. |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
19 Years
Sexos elegíveis
Todos
- 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 .
- 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.
MicrobiotiX Co., LtdContato central do estudo
Contato: Sangmin Lee, Director, 82-10-2807-7489, [email protected]
1 Locais do estudo em 1 países
Seodaemun-gu
Severance Hospital, Seoul, Seodaemun-gu, 03722, South Korea
Jun Yong Choi, Professor, Contato, 82-2-2228-1974, [email protected]