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El ensayo clínico NCT07495813 para Stable Coronary Artery Disease, Voluntarios sanos está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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RocheA Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease Fase I 196
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07495813 está diseñado para estudiar el tratamiento de Stable Coronary Artery Disease, Voluntarios sanos. Es un estudio intervencionista de Fase I. Su estado actual es: reclutando. El estudio se inició el 31 de marzo de 2026, con el objetivo de reclutar a 196 participantes. Dirigido por Roche, se espera que finalice el 31 de diciembre de 2027. Los datos se actualizaron por última vez en ClinicalTrials.gov el 27 de marzo de 2026.
Resumen
This study will evaluate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses (SAD) (Part 1a), multiple ascending doses (MAD) (Part 1b), and the food effect (Part 1c) of RO7763505 in healthy adult participant. In Part 2, the safety, tolerability, PK and PD of multiple doses of RO7763505 in participants with stable coronary artery diseases (CAD).
Título oficial
A Phase I, Randomized, Double-Blind, Adaptive, Placebo-Controlled, Single- Ascending Dose and Multiple-Ascending Dose, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of RO7763505 Following Oral Administration in Healthy Participants and Patients With Stable Coronary Artery Disease
Condiciones médicas
Stable Coronary Artery DiseaseVoluntarios sanosOtros ID del estudio
- BP46355
- 2025-524693-42-00 (Número CTIS (UE))
Número del NCT
Inicio del estudio (real)
2026-03-31
Última actualización
2026-03-27
Fecha de finalización (estimada)
2027-12-31
Inscripción (prevista)
196
Tipo de estudio
Intervencionista
FASE
Fase I
Estado general
Reclutando
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Triple ciego
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalPart 1: SAD, MAD, and Food Effect in Healthy Participants Healthy participants will receive RO7763505 or matching placebo. | RO7763505 Participants will receive RO7763505 as per the schedule described in the protocol. PLACEBO Participants will receive matching placebo as per the schedule described in the protocol. |
ExperimentalPart 2: In Stable CAD Participants Participants with stable CAD will receive RO7763505 or matching placebo. | RO7763505 Participants will receive RO7763505 as per the schedule described in the protocol. PLACEBO Participants will receive matching placebo as per the schedule described in the protocol. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Part 1a and Part 1b: Percentage of Participants With Adverse Events (AEs) | Part 1a: Approximately up to 2 Weeks; Part 1b: Approximately up to 3 Weeks | |
Part 1c: Plasma Concentration of RO7763505 in Fasted and fed State | Approximately up to 3 Weeks | |
Part 2: Percentage of Participants With AEs | Approximately up to 6 Weeks |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Part 1a and Part 1b: Plasma Concentration of RO7763505 and its Metabolites | Part 1a: Approximately up to 2 Weeks; Part 1b: Approximately up to 3 Weeks | |
Part 1a and Part 1b: Percentage Change From Baseline in Inhibition of Ex Vivo-Stimulated Interleukin-1 Beta ( IL-1β) | Part 1a: Baseline, Approximately up to 2 Weeks; Part 1b: Baseline, Approximately up to 3 Weeks | |
Part 1c: Percentage of Participants With AEs | Approximately up to 3 Weeks | |
Part 2: Plasma Concentration of RO7763505 and its Metabolites | Approximately up to 6 Weeks | |
Part 2: Percentage Change From Baseline in Inhibition of Ex Vivo-Stimulated IL-1β | Baseline, Approximately up to 6 Weeks |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
Admisión de voluntarios sanos
Sí
Part 1:
- Healthy biologically male and female participants of nonchildbearing potential or childbearing potential with no clinically relevant findings on physical examination at screening or baseline (assessed either on Day -2 or Day -1), including detailed medical and surgical history, vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology, and urinalysis
- No suspicion of cognitive impairment/dementia as judged by the Investigator
Part 2:
- Myocardial infarction before the screening visit
- Objective imaging evidence (coronary computed tomography \[CT\] angiography or invasive angiography) of coronary atherosclerosis Participants who underwent percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) are eligible if the procedure was done >6 months prior to screening
- A diagnosis of stable CAD, defined as being on stable guideline-directed medical therapy (GDMT) if tolerated for at least 90 days prior to screening with no planned changes or scheduled interventions during the study
- QTc of <= 450 milliseconds (ms) as determined by a single 12-lead ECG recording. If the initial ECG result of the triplicate is exclusionary, consecutive repeat ECG results must be within the acceptable limits. In participants with a stable bundle branch block where the QRS duration is > 120 ms, the QTcF will be calculated as: QTcF - (QRS - 100 ms)
Part 1:
- Any condition or disease detected during the medical interview/physical examination that would render the participant unsuitable for the study, place the participant at undue risk, or interfere with the ability of the participant to complete the study in the opinion of the Investigator
- Vaccination within 28 days prior to Day 1 (non-live vaccines including influenza vaccination are permitted 14 days prior to Day 1) or planned before the end of the study. Investigators are advised to review the immunization status of participants who are considered for treatment with RO7763505 and follow local/national guidance for adult vaccination against infectious disease as they deem relevant
- Positive result on human immunodeficiency virus (HIV)-1 and HIV-2, hepatitis B virus (HBV) (either hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\]), hepatitis C virus (HCV) antibody test, or tuberculosis (TB)
Part 2:
- Individuals with New York Heart Association (NYHA) Class III or IV heart failure
- Known or suspected immunocompromised state
- Treatment with any investigational therapy within 28 days or within five drug-elimination half-lives (whichever is longer; or longer than either if required by local regulations; if the half-life is unknown, the 90-day period applies) prior to Day 1, calculated from the day of the follow-up from the previous study
RocheContactos centrales del estudio
Contacto: Reference Study ID Number: BP46355 https://forpatients.roche.com/, 888-662-6728 (U.S. and Canada), [email protected]
1 Centros del estudio en 1 países
ICON Plc (LPRA) - Netherlands, Groningen, 9728 NZ, Netherlands
Reclutando