- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05574166
A Phase I Study to Evaluate Safety and Pharmacokinetics of Escalating Single Doses and Multiple Doses of SP-8356
6 de octubre de 2022 actualizado por: Shin Poong Pharmaceutical Co. Ltd.
A Phase I Single-Centre, Randomised, Double-Blind, Placebo-Controlled Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses and Multiple Doses of SP-8356
This is a 2-part, single-centre, randomised study in healthy males.
Part 1 is a double-blind, randomised, placebo-controlled, single ascending dose (SAD) study in healthy males.
Part 2 is a double-blind, randomised, placebo-controlled, multiple ascending dose (MAD) study in healthy males.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
2-part, single-centre, randomised study in healthy males.
Part 1 is a double-blind, randomised, placebo-controlled, single ascending dose (SAD) study in healthy males.
Part 2 is a double-blind, randomised, placebo-controlled, multiple ascending dose (MAD) study in healthy males.
Tipo de estudio
Intervencionista
Inscripción (Actual)
31
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.
Ubicaciones de estudio
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Mere Way Ruddington Fields Ruddington
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Nottingham, Mere Way Ruddington Fields Ruddington, Reino Unido, NG11 6JS
- Quotient Sciences
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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
18 años a 55 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Masculino
Descripción
Inclusion Criteria:
- Healthy males
- Aged 18 to 55 years, inclusive, at the time of signing informed consent
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Must agree to adhere to the contraception requirements
Exclusion Criteria:
- Females
- Subjects who have received any IMP in a clinical research study within the 90 days prior to the planned first dosing date
- Subjects who are, or are immediate family members of a study site or sponsor employee
- Evidence of recent or current SARS-CoV-2 infection. A minimum period of 3 months from resolution of COVID-19 symptoms to dosing must have passed
- Subjects who have previously been administered IMP in this study.
- Subjects who have taken part in Part 1 are not permitted to take part in Part 2
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males > 21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
- A confirmed positive alcohol breath test at screening or admission
- Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
- Clinically significant abnormal biochemistry, haematology, or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are not allowed
- Subjects that have either a known of family history of QT prolongation or chronic QT prolongation syndrome (i.e. QTc > 450 msec) in repeated ECG
- Subjects with any clinically significant medical disorders increasing tendency to bleed easily, or having history of recent trauma or surgery, or having history of gout or renal stones
- Subjects with a clinically significant history of skin disorder such as photosensitivity, eczema or psoriasis.
- Subjects with a clinically significant history of eye disorders that may affect the interpretation of the ophthalmology assessments as per the judgement of the investigator (only for subjects where ophthalmology assessments will be performed).
- Confirmed positive drugs of abuse test result
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
- Evidence of renal impairment at screening, as indicated by an estimated glomerular filtration rate (eGFR) of <80 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- Subjects with a history of cholecystectomy or gall stones (Part 1 Cohort 3 only)
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Has a history of photosensitivity or photoallergy
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day) in the 14 days before IMP administration Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as determined by the investigator
- Is taking medication known to cause phototoxic reactions (e.g., tetracyclines, thiazides, nonsteroidal anti-inflammatory drugs) within 4 weeks of enrolling into the study
- Failure to satisfy the investigator of fitness to participate for any other reason
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 paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: SP-8356 powder
Part1 will consist of escalating single doses in five sequential cohorts.
Each dose level cohort will consist of 8 subjects: 6 subjects will receive SP-8356 and 2 subjects will receive placebo in fasted state according to the randomization schedule.
Subjects in Cohort 3 will receive a single dose of SP-8356 or placebo in the fasted then fed state on separate dosing occasions.
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SP-8356 demonstrates anti-atherosclerotic and anti-ischaemic activity as a novel CD147 inhibitor.
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Comparador de placebos: Placebo
Part1 will consist of escalating single doses in five sequential cohorts.
Each dose level cohort will consist of 8 subjects: 6 subjects will receive SP-8356 and 2 subjects will receive placebo in fasted state according to the randomization schedule.
Subjects in Cohort 3 will receive a single dose of SP-8356 or placebo in the fasted then fed state on separate dosing occasions.
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Placebo for SP-8356 powder
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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(Part 1)To investigate the safety and tolerability of single oral doses of SP-8356 in healthy male subjects
Periodo de tiempo: up to 3days
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Incidence of adverse events (AEs), and assessment of physical examinations, safety laboratory tests, vital signs, electrocardiograms (ECGs) and ophthalmologic examinations
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up to 3days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
(Part 1)To characterise the pharmacokinetic (PK) profile of single oral doses of SP-8356 Maximum Observed Drug Concentration (Cmax)
Periodo de tiempo: up to 3days
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Evaluate Maximum Observed Drug Concentration (Cmax) of SP-8356.
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up to 3days
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(Part 1)]To characterise the pharmacokinetic (PK) profile of single oral doses of SP-8356- Area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞])
Periodo de tiempo: up to 3days
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Evaluate Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of SP-8356.
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up to 3days
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(Part 1)To characterise the effect of food on the PK profile of SP-8356 following single oral doses of SP-8356 Maximum Observed Drug Concentration (Cmax)
Periodo de tiempo: up to 3days
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Evaluate the effect of food on Maximum Observed Drug Concentration (Cmax) of SP-8356.
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up to 3days
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(Part 1)To characterise the effect of food on the PK profile of SP-8356 following single oral doses of SP-8356 - Area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞])
Periodo de tiempo: up to 3days
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Evaluate the effect of food on Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of SP-8356.
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up to 3days
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Stuart Mair, MD, PhD, Quotient Sciences
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)
3 de enero de 2021
Finalización primaria (Actual)
28 de octubre de 2021
Finalización del estudio (Actual)
29 de octubre de 2021
Fechas de registro del estudio
Enviado por primera vez
6 de octubre de 2022
Primero enviado que cumplió con los criterios de control de calidad
6 de octubre de 2022
Publicado por primera vez (Actual)
10 de octubre de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de octubre de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
6 de octubre de 2022
Última verificación
1 de octubre de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SP-8356-1001
- 2020-001216-23 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
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. .
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