A Phase 1a/1b Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmacokinetics of Inhaled Rev-56 in Adult Healthy Volunteers and Adult Non-cystic Fibrosis Bronchiectasis (NCFB) Patients With Chronic P. Aeruginosa
27 de julio de 2026 actualizado por: Revagenix, Inc.
A Sequential, Phase 1a/1b, Double-blind, 2-part Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmacokinetics of Rev-56 for Inhalation Compared With Placebo in Healthy Adult Participants and Adult Non-cystic Fibrosis Bronchiectasis (NCFB) Patients With Chronic Pseudomonas Aeruginosa
This is a Phase 1a/1b study to test the safety, tolerability, microbiological response, and pharmacokinetics of inhaled Rev-56 compared to placebo in adult healthy participants and non-cystic fibrosis bronchiectasis (NCFB) patients with P. aeruginosa, respectively.
Phase 1a (Part A) will evaluate single doses of inhaled Rev-56 in adult healthy participants and includes up to 5 cohorts. Eligible participants will be randomized to active treatment or placebo in a 3:1 randomization scheme.
Phase 1b (Part B) will evaluate the safety, tolerability, microbiological response, and pharmacokinetics of multiple doses of inhaled Rev-56 in NCFB patients with P. aeruginosa and includes 2 cohorts evaluating once daily dosing and twice daily dosing, respectively. Eligible participants will be randomized to active treatment or placebo in a 2:1 randomization scheme.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
64
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Chrissy Morgenthaler
- Número de teléfono: 619-512-3538
- Correo electrónico: revagenixclinicaltrials@revagenix.com
Ubicaciones de estudio
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Florida
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Miami, Florida, Estados Unidos, 33136
- Reclutamiento
- Syneos Health Miami
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria (Healthy Participants):
- Healthy male and female participants aged 18 to 55 years, inclusive
- Body mass index > 18 to ≤ 32 kg/m^2
- Forced expiratory volume in 1 second (FEV1) ≥ 80%
- Creatinine clearance ≥ 90 mL/min
- Normal laboratory values and physical exam at screening, or Grade 1 abnormalities that are not clinically significant
Inclusion Criteria (NCFB Patients with P. aeruginosa):
- Male and female NCFB patients aged 18 to 80 years, inclusive
- Bronchiectasis confirmed by prior computerized tomography (CT) scan
- Chronic P. aeruginosa infection (≥ 2 positive cultures within prior 12 months)
- Screening sputum culture positive for P. aeruginosa at ≥ 10^4 CFU/mL
- FEV1 ≥ 50% (post bronchodilator)
Exclusion Criteria (Healthy Participants):
- Clinically significant medical history
- Acute illness within 4 weeks of screening
- Current smoker or nicotine user
- History of alcohol abuse (within prior 12 months) or drug/chemical abuse
Exclusion Criteria (NCFB Patients with P. aeruginosa):
- Primary asthma, chronic obstructive pulmonary disease (COPD), or cystic fibrosis (CF)
- More than 2 pulmonary exacerbations requiring IV antibiotics within 12 months prior to screening
- Receipt of antibiotics (excluding macrolides) within 30 days prior to screening
- Clinically significant hemoptysis requiring intervention within 30 days prior to screening
- Receiving anti-infective treatment for concurrent nontuberculosis mycobacteria (NTM) or fungal infection
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Cohort 1a
3.5 mg Rev-56 or placebo single dose
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administered by inhalation via an investigational nebulizer device
administered by inhalation via an investigational nebulizer device
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Experimental: Cohort 2a
7 mg Rev-56 or placebo single dose
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administered by inhalation via an investigational nebulizer device
administered by inhalation via an investigational nebulizer device
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Experimental: Cohort 3a
14 mg Rev-56 or placebo single dose
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administered by inhalation via an investigational nebulizer device
administered by inhalation via an investigational nebulizer device
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Experimental: Cohort 4a
28 mg Rev-56 or placebo single dose
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administered by inhalation via an investigational nebulizer device
administered by inhalation via an investigational nebulizer device
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Experimental: Optional Cohort 5a
≤56 mg Rev-56 or placebo single dose
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administered by inhalation via an investigational nebulizer device
administered by inhalation via an investigational nebulizer device
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Experimental: Cohort 1b
≤28 mg Rev-56 or placebo once daily for 7 days
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administered by inhalation via an investigational nebulizer device
administered by inhalation via an investigational nebulizer device
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Experimental: Cohort 2b
≤28 mg Rev-56 or placebo twice daily for 7 days
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administered by inhalation via an investigational nebulizer device
administered by inhalation via an investigational nebulizer device
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Incidence and severity of treatment-emergent adverse events (AEs)
Periodo de tiempo: 21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa)
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21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa)
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Number of participants with clinically significant abnormalities in lab parameters, vital signs, respiratory function, and ECG parameters graded by FDA Toxicity Grading Scale (for healthy participants) and DAIDS Toxicity Tables (for NCFB patients)
Periodo de tiempo: 21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa)
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21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa)
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Maximum observed concentration (Cmax) of Rev-56
Periodo de tiempo: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Time to Cmax of Rev-56 (Tmax)
Periodo de tiempo: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Area under the curve from time 0 to last measurable concentration (AUC0-last)
Periodo de tiempo: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Area under the curve from time 0 to 24 hours after completion of dosing (AUC0-24)
Periodo de tiempo: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Area under the curve from time 0 to infinity (AUC0-inf)
Periodo de tiempo: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Clearance of Rev-56 (CL/F)
Periodo de tiempo: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Half-life of Rev-56 (t½)
Periodo de tiempo: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Volume of distribution of Rev-56 (Vz/F)
Periodo de tiempo: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Minimum observed concentration of Rev-56 (Cmin)
Periodo de tiempo: NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
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Mean P. aeruginosa burden (CFU/mL) in sputum culture compared to baseline
Periodo de tiempo: 28 days (NCFB patients with P. aeruginosa)
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28 days (NCFB patients with P. aeruginosa)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
13 de julio de 2026
Finalización primaria (Estimado)
1 de junio de 2027
Finalización del estudio (Estimado)
1 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
2 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
13 de julio de 2026
Publicado por primera vez (Actual)
16 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Rev-56-001
- 75N93022C00061 (Otro identificador: NIAID)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
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