A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis
22 de abril de 2026 actualizado por: Sitryx Therapeutics Ltd
A Multi-part, FiH Study in Healthy Participants and Participants With Atopic Dermatitis (AD) to Assess the Safety, Tolerability, Pharmacokinetics (PK) of Single & Multiple Ascending Doses and Selected Dose of SYX-5219 (AD Participants).
The purpose of this study is to evaluate the study drug, SYX-5219, in a multi-part First-in-Human (FiH) study to be conducted in healthy volunteers and participants with Atopic Dermatitis (AD). The objectives of this study are to determine the safety, tolerability and levels of SYX-5219 in the blood and urine when SYX-5219 is given in each part of the study (SAD, MAD, Food Effect and Participants with AD).
The study will be split into up to 3 parts as follows:
- Part 1 - Single Ascending Dose (SAD) and Food Effect in healthy volunteers
- Part 2 - Multiple Ascending Dose (MAD) in healthy volunteers
- Part 3 - Multiple Dose in Participants with AD - enrolling up to 45 males and females with a confirmed diagnosis of AD of at least 6 months, evaluating multiple dose administrations of SYX-5219 or placebo daily over a period of 42 days.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a multi-part, adaptive, Phase 1, double-blind, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of SYX-5219 following single ascending doses (SAD), multiple ascending doses (MAD), and selected dosing in participants with atopic dermatitis (AD).
Parts 1 and 2 will be conducted at a single site in the UK. Part 3 will be conducted globally at multiple sites.
Part 1 (Single Ascending Dose & Food Effect) Part 1 (SAD) will enrol up to 48 healthy participants in cohorts (3:1, active:placebo). Participants will receive single doses of SYX-5219, with a food effect evaluation including a second dosing period following washout.
Part 2 (Multiple Ascending Dose) Part 2 (MAD) will enrol up to 24 healthy participants in cohorts (3:1, active:placebo). Participants will receive multiple doses of SYX-5219 over a defined treatment period.
Part 3 (AD Participants) Part 3 will enrol up to 45 participants with AD across multiple global sites. Participants will be randomised (2:1) to receive SYX-5219 or placebo for up to 42 days. Prior exposure to targeted systemic therapy will be limited. Study assessments will include safety and exploratory efficacy evaluations during treatment and follow-up.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
149
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: Sitryx Therapeutics
- Número de teléfono: +44 (0)1865 648401
- Correo electrónico: info@sitryx.com
Copia de seguridad de contactos de estudio
- Nombre: Sitryx Therapeutics
- Número de teléfono: +44 (0) 1865 648401
- Correo electrónico: info@sitryx.com
Ubicaciones de estudio
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Berlin, Alemania, 10117
- Reclutamiento
- Sitryx Clinical Site
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Frankfurt, Alemania, 60596
- Reclutamiento
- Sitryx Clinical Site
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Freiburg im Breisgau, Alemania, 79106
- Activo, no reclutando
- Sitryx Clinical Site
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Sofia, Bulgaria, 1404
- Reclutamiento
- Sitryx Clinical Site
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Herlev
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Herlev, Herlev, Dinamarca, 2730
- Aún no reclutando
- Sitryx Clinical Site
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Arkansas
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Arkansas City, Arkansas, Estados Unidos, 72117
- Reclutamiento
- Sitryx Clinical Site
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California
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Fremont, California, Estados Unidos, 94538
- Reclutamiento
- Sitryx Clinical Site
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Indiana
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Plainfield, Indiana, Estados Unidos, 46168
- Reclutamiento
- Sitryx Clinical Site
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Ohio
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Boardman, Ohio, Estados Unidos, 44512
- Reclutamiento
- Sitryx Clinical Site
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19103
- Reclutamiento
- Sitryx Clinical Site
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Utah
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Bountiful, Utah, Estados Unidos, 84010
- Reclutamiento
- Sitryx Clinical Site
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Dublin, Irlanda, D08 NHY1
- Reclutamiento
- Sitryx Clinical Site
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Manchester, Reino Unido, M23 9QZ
- Reclutamiento
- Sitryx Clinical Site
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Merthyr Tydfil, Reino Unido, CF48 4DR
- Reclutamiento
- Sitryx Clinical Site
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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:
Parts 1 & 2
- Healthy male and female participant, between ≥ 18 to ≤ 65 years of age, inclusive, with a BMI of body mass index (BMI) of 18-32 kg/m2.
- Female participant of non-childbearing potential or female of childbearing potential that is sexually abstinent.
- No clinically significant abnormalities in laboratory, vital signs or ECG measurements.
Part 3
- Male and female participants with clinically confirmed diagnosis of active AD, between ≥ 18 to ≤ 65 years of age, inclusive, with a BMI of body mass index (BMI) of ≤40 kg/m2.
Meet minimum AD entry criteria;
- AD covering ≥10% of the body surface area (BSA) at screening and baseline.
- Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline.
- Validated Investigator's Global Assessment (vIGA) score of ≥ 3 (moderate) at screening and baseline.
- Peak Pruritus NRS score of ≥ 4 at screening and baseline.
Exclusion Criteria:
Parts 1 & 2
• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 35 days or 5 half-lives (whichever is longer) prior to the first dose of IMP.
Part 3
- Any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the Investigator, put the participant at undue risk.
- Has medical history as stated in the main study exclusion criteria.
- Received treatment(s) as stated in the main study exclusion criteria.
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Part 1 Single Ascending Dose (SAD)
Single dose of SYX-5219 (active or matching placebo) administered on Day 1 for all cohorts and Day 1 of each treatment period for food effect cohorts (in fasted and fed conditions).
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Oral Capsule to be administered at each specific dose level within each cohort
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Experimental: Part 2 Multiple Ascending Dose (MAD)
Multiple doses of SYX-5219 (active or matching placebo) administered once or twice daily for all cohorts.
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Oral Capsule to be administered at each specific dose level within each cohort
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Experimental: Part 3 AD Participants Multiple Doses
Multiple doses of SYX-5219 (active or matching placebo) administered twice daily for multiple dose administration
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Oral Capsule to be administered at each specific dose level within each cohort
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The Proportion of Participants With Treatment-Emergent Adverse Events
Periodo de tiempo: Adverse events are collected from the date of consent until up to 10 days after the dose in Part 1 (Day 11), 14 days after the last dose in Part 2 (Day 28) and up to Day 56 in Part 3.
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The number of participants who reported a treatment-emergent adverse event (TEAE) will be summarised.
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Adverse events are collected from the date of consent until up to 10 days after the dose in Part 1 (Day 11), 14 days after the last dose in Part 2 (Day 28) and up to Day 56 in Part 3.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Concentrations of SYX5219 in Plasma
Periodo de tiempo: For Part 1: 14 timepoints from pre-dose Day 1 up to 120 h post-dose Day 6. For Part 2: 28 timepoints from pre-dose Day 1 up to Day 19. For Part 3: 8 timepoints from pre-dose Day 1 up to Day 56.
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Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for SYX-5219.
This endpoint will report the summary of derived pharmacokinetic parameters for participants in all parts of the study.
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For Part 1: 14 timepoints from pre-dose Day 1 up to 120 h post-dose Day 6. For Part 2: 28 timepoints from pre-dose Day 1 up to Day 19. For Part 3: 8 timepoints from pre-dose Day 1 up to Day 56.
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Concentrations of SYX5219 in Urine
Periodo de tiempo: For Part 1: continuous urine collection from Day 1 up to 48 hr post-dose on Day 2. For Part 2: continuous urine collection from Day 1 up to 48 hr post-dose on Day 2 and Day 14 up to 48 hr post-dose on Day 16.
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Urine samples were obtained in order to evaluate defined urine pharmacokinetic parameters for SYX-5219.
This endpoint will report the summary of derived pharmacokinetic parameters for participants in Part 1 and Part 2 of the study.
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For Part 1: continuous urine collection from Day 1 up to 48 hr post-dose on Day 2. For Part 2: continuous urine collection from Day 1 up to 48 hr post-dose on Day 2 and Day 14 up to 48 hr post-dose on Day 16.
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Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
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Percent change from baseline in the Eczema Area and Severity Index (EASI) - Part 3
Periodo de tiempo: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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Proportion of participants achieving a 50% 75% and 90% reduction of EASI (EASI50 and EASI75 and EASI90) - Part 3
Periodo de tiempo: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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Proportion of participants achieving a minimum 2- grade improvement from baseline in validated Investigator Global Assessment (vIGA) score to clear (0) or almost clear (1) - Part 3
Periodo de tiempo: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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Percent change from baseline in peak pruritus numeric rating scale (PP-NRS) - Part 3
Periodo de tiempo: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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Proportion of participants with ≥3-point and ≥4-point improvement in peak pruritus numeric rating scale - Part 3
Periodo de tiempo: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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Percent change from baseline in weekly average of the daily PP-NRS scores - Part 3
Periodo de tiempo: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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Percent change from baseline in weekly average of the daily sleep loss scores - Part 3
Periodo de tiempo: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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Change from baseline and percent change from baseline in percent atopic dermatitis covering the body surface area (BSA) involvement - Part 3
Periodo de tiempo: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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Change from baseline in Dermatology Life Quality Index (DLQI) - Part 3
Periodo de tiempo: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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Change from baseline in Patient Orientated Eczema Measure (POEM) - Part 3
Periodo de tiempo: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Sitryx Therapeutics, Study Sponsor
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 febrero de 2025
Finalización primaria (Estimado)
30 de agosto de 2026
Finalización del estudio (Estimado)
30 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
22 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
22 de abril de 2026
Publicado por primera vez (Actual)
30 de abril de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de abril de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
22 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- SYX-5219-101
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
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .