Phase 1 Study Evaluating Safety and Pharmacokinetics of ASY202 in Adults With Asthma
1 de septiembre de 2026 actualizado por: Aspeya, Inc.
A Phase 1 Randomized, Double-blind, Placebo-controlled, Crossover Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single-dose of ASY202 in Adults With Asthma
This is a phase 1 study, randomized, double-blind, placebo-controlled, 2 treatment, 2 period crossover study to evaluate the pharmacokinetics, safety, and tolerability of a single inhaled dose of ASY202 in adults with stable asthma.
Following screening, eligible participants will be enrolled and randomized to one of two treatment sequences. Participants will receive a single inhaled dose of ASY202 and a single inhaled dose of placebo, each administered once during separate study periods.
During each treatment period, subjects will stay in the clinical research unit for safety monitoring and PK assessments, including serial blood sampling, spirometry, vital signs, clinical laboratory tests, and ECGs. Each period will include post dose assessments for up to 24 hours.
Participants will return for their next treatment period after a washout interval to ensure complete clearance of study medication. All subjects will receive both treatments over the course of the study.
A follow-up visit will occur after the last dose to assess ongoing safety and tolerability.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
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: Guillaume Crespel
- Número de teléfono: + 41 78 688 05 43
- Correo electrónico: clinicaltrials@aspeya.com
Ubicaciones de estudio
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Arizona
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Glendale, Arizona, Estados Unidos, 85304
- Activo, no reclutando
- Sun City Clinical Research
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California
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Anaheim, California, Estados Unidos, 92801
- Reclutamiento
- CenExel- Anaheim Clinical trials LLC
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Contacto:
- Amina Z. Haggag, Dr.
- Número de teléfono: 1012 714-774-7777
- Correo electrónico: a.haggag@cenexel.com
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Investigador principal:
- Amina Z. Haggag, Dr.
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Texas
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San Antonio, Texas, Estados Unidos, 78217
- Retirado
- Worldwide Clinical Trials- Early Phase Research Unit
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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
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Adults aged 18-55 years
- Diagnosed asthma
- Stable asthma treatment
- Non smoker
- BMI 18.5-35 kg/m²
- Women of childbearing potential and men agree to use acceptable contraception
Exclusion Criteria:
- Asthma exacerbation requiring systemic steroids, ER visit, or hospitalization within 3 months
- Respiratory tract infection within 4 weeks prior to screening
- Use of oral or IV corticosteroids
- Use of prohibited medications (e.g., CYP3A4 modulators, triptans, vasoconstrictors, QT prolongers, theophylline, systemic steroids)
- Other lung diseases (e.g., Chronic Obstructive Pulmonary Disease (COPD)) or conditions interfering with spirometry
- Unstable asthma or unresolved safety concerns before dosing
- Clinically significant cardiovascular disease or ECG abnormalities contraindicating DHE
- Three or more risk factors for Coronary Artery Disease (CAD) (hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, females who are surgically or physiologically postmenopausal, or males who are over 40 years of age)
- Pregnancy, breastfeeding, or unwillingness to use required contraception
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: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: ASY202, then placebo
ASY202 is a pre-metered drug-device combination product containing DHE dry powder formulation for oral inhalation, delivered via a dry powder inhaler (DPI) device.
In Treatment Period 1, participants will receive ASY202, followed by a washout period and subsequent administration of placebo in Treatment Period 2. The placebo consists of an inactive inhalation powder delivered via a matching DPI device.
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ASY202 is a pre-metered drug-device combination product containing a dry-powder formulation of dihydroergotamine (DHE) intended for oral inhalation, delivered via a dry powder inhaler (DPI).
Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.
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Experimental: Placebo, then ASY202
In Treatment Period 1, participants will receive placebo inhalation powder delivered via a dry powder inhaler (DPI) device, followed by a washout period and subsequent administration of ASY202 in Treatment Period 2.
|
ASY202 is a pre-metered drug-device combination product containing a dry-powder formulation of dihydroergotamine (DHE) intended for oral inhalation, delivered via a dry powder inhaler (DPI).
Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Effect of a single dose of ASY202 2 mg compared with placebo on pulmonary function in adults with asthma.
Periodo de tiempo: Post dose 5 minutes, 15 minutes, 40 minutes, 1hour, 2 hours and 4 hours.
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Percentage change from baseline in FEV1 over time measured by spirometry at predefined timepoints post-dose (5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours), following administration of investigational product.
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Post dose 5 minutes, 15 minutes, 40 minutes, 1hour, 2 hours and 4 hours.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Periodo de tiempo: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.
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Change from baseline in FVC at any of the post-dose time points.
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Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.
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Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Periodo de tiempo: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours
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Change from baseline in FEV1/FVC ratio at any of the post-dose time points
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Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours
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Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Periodo de tiempo: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours
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Change from baseline in FEF 25-75 at any of the post-dose time points
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Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours
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Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma
Periodo de tiempo: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours
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Proportion of participants with ≥20%, ≥15%, ≥10% reduction in FEV1 from baseline at any of the post-dose time points.
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Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours
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Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of a single dose of ASY202 2 mg compared with placebo in adults with asthma.
Periodo de tiempo: Up to 24 hours post dose and safety follow up to seven days after last dose
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Incidence and severity of Treatment Emergent Adverse Events (TEAEs)
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Up to 24 hours post dose and safety follow up to seven days after last dose
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Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma.
Periodo de tiempo: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
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AUC0-t, AUC0-inf, AUC0-30min and AUC0-2h of plasma concentrations of DHE and 8'-OH-DHE of DHE and its metabolite
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Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
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Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma.
Periodo de tiempo: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
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Cmax of plasma concentrations of DHE and 8'-OH-DHE
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Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
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Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma.
Periodo de tiempo: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
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Tmax of plasma concentrations of DHE and 8'-OH-DHE
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Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
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Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma
Periodo de tiempo: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
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Kel of plasma concentrations of DHE and 8'-OH-DHE
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Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
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Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma
Periodo de tiempo: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
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T1/2 el of plasma concentrations of DHE and 8'-OH-DHE
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Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
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Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma
Periodo de tiempo: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
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CL/F during the terminal phase of DHE
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Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
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Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma
Periodo de tiempo: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
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Vz/F during the terminal phase of DHE
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Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
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Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Periodo de tiempo: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.
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Change from baseline in FEV1 in absolute value at post-dose time points
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Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.
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Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Periodo de tiempo: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.
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Change from baseline in FEV1 in % predicted at post-dose time points
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Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.
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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)
26 de mayo de 2026
Finalización primaria (Estimado)
1 de marzo de 2027
Finalización del estudio (Estimado)
1 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
27 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
18 de junio de 2026
Publicado por primera vez (Actual)
24 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- VFC202-103
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.
No
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