- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04839926
A Single Ascending Dose Study Of CY150112 After Single Oral Administration in Healthy Chinese Subjects
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase I Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of CY150112 After Single Oral Administration in Healthy Chinese Subjects
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Single administration, double-blinded, placebo-controlled (2 subjects in each group will take placebo,8 subjects in each group will take CY150112) and 6 dose groups (0.5mg, 1.5mg, 4.5mg, 10mg, 18mg and 24mg).
This study comprises a screening period (between signing of the informed consent form and Day -1), baseline period (Day -1), treatment period (Days 1-5) and follow-up period(Days 12 or 7 days after discharge ).
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hua Fang li, MD
- Número de teléfono: 021-34773107
- Correo electrónico: lhlh_5@163.com
Copia de seguridad de contactos de estudio
- Nombre: Li Yan, Research Doctor
- Número de teléfono: 021-34773107
- Correo electrónico: lhlh_5@163.com
Ubicaciones de estudio
-
-
Shanghai
-
Shanghai, Shanghai, Porcelana, 200030
- Reclutamiento
- Shanghai Mental Health Center
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Contacto:
- Hua Fang li, MD
- Número de teléfono: 021-34773107
- Correo electrónico: lhlh_5@163.com
-
Contacto:
- Li Yan, Research Doctor
- Número de teléfono: 021-34773107
- Correo electrónico: lhlh_5@163.com
-
Investigador principal:
- Hua Fang Li, MD
-
Sub-Investigador:
- Li Yan, Research Doctor
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Male/female subjects are 18<age ≤45 years of age when signing the informed consent.
- Male Subjects with body weight of ≥50.0kg ,and female Subjects with body weight of ≥45.0kg and BMI (body mass index) of 18.5≤ and <28.0 at screening examination.
- After detailed explanations of study objectives, contents and procedures, and possible risks, subjects are aware of all relevant information related to this study and have signed the written informed consent form voluntarily.
- Subjects are able to communicate well with researchers, be willing and able to comply with the lifestyle restrictions stipulated during this study period, and cooperate to complete this study.
Exclusion Criteria:
- The investigator determined that the subjects' present medical history and past medical history had any disease or dysfunction that would affect the clinical trial, including but not limited to diseases of the central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, hematological system, etc.
- There is any surgical condition or disease that may significantly affect the absorption, distribution, metabolism and excretion of drugs, or may harm to the subjects participating in the trial; such as history of gastrointestinal operations (gastrectomy, gastroenterostomy, enterectomy, etc.), urinary tract obstruction or dysuria, gastroenteritis, digestive tract ulcers, history of gastrointestinal bleeding, etc.
- Subjects with past history of allergy to drugs or allergic disease.
- Subjects with currently or past history of mental disorders and brain functional disorders.
- According to the Columbia suicide severity scale (C-SSRS), subjects were at risk of suicide or were at risk of suicide based on the clinical judgment of the researchers, or with past history of self-injurious behavior.
- Subjects have history of drug abuse or positive urine drug tests at screening within 1 year prior.
- Subjects have history of alcohol abuse(i.e.,criteria are per week consumption more than 14 standard units(1 unit =360mL beer or 45mL 40% alcohol of Chinese liquor or 150mL wine)or positive alcohol breath tests at screening within 1 year prior.
- Average amount of daily smoking>5 cigarettes at screening 3 months prior.
- Those who have special requirements for food, cannot follow a uniform diet or have difficulty swallowing.
- Female subjects who are pregnant and lactating ; and those who refuse to use effective non-drug contraceptive measures (such as abstinence, intrauterine device) or have planned to donate sperm or ovum throughout the study period and within 3 months after the end of the study.
- Abnormal vital signs, lab and ECG indicators, as determined by the researcher, and clinically significant (e.g., male QTC > 450ms female > 470ms,corrected by Friericia ).
- Subjects who resting heart rate <55 beats/min or >100 beats/min; systolic blood pressure <90mmHg or >140mmHg; diastolic blood pressure <60mmHg or >90mmHg.
- Subjects who hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab), or HIV antibody (HIV-Ab), or syphilis serum reaction (TRUST) is non-negative.
- Subjects who glutamic-pyruvic transaminase(ALT), creatinine (Cr), urea nitrogen (BUN) exceeding the normal upper limit or the level of serum prolactin is 2 times higher than the normal upper limit.
- Subjects who participated in any clinical trial within 3 months before medication.
- Subjects have history of blood donations of 400 mL within 3 months before enrollment; 200 mL within 1 month before enrollment; or have history of using blood products.
- Subjects who had a history of surgery within 3 months prior to enrollment, or did not recover from surgery, or had an expected surgical plan during the study period.
- Subjects who had taken any drugs, including prescription and over-the-counter drugs within 2 weeks prior to enrollment.
- Subjects who directly related to this clinical trial.
- Subjects have poor compliance or other problems that the researchers believe that it is not suitable for participating.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 0.5mg CY150112
single oral CY150112 while fasting on day 1.
|
single oral CY150112 while fasting on day 1.
Otros nombres:
|
Experimental: 1.5mg CY150112
single oral CY150112 while fasting on day 1.
|
single oral CY150112 while fasting on day 1.
Otros nombres:
|
Experimental: 4.5mg CY150112
single oral CY150112 while fasting on day 1.
|
single oral CY150112 while fasting on day 1.
Otros nombres:
|
Experimental: 10mg CY150112
single oral CY150112 while fasting on day 1.
|
single oral CY150112 while fasting on day 1.
Otros nombres:
|
Experimental: 18mg CY150112
single oral CY150112 while fasting on day 1.
|
single oral CY150112 while fasting on day 1.
Otros nombres:
|
Experimental: 24mg CY150112
single oral CY150112 while fasting on day 1.
|
single oral CY150112 while fasting on day 1.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Incidence of AEs
Periodo de tiempo: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Incidence of Adverse Events
|
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Cmax
Periodo de tiempo: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Maximum (peak) observed drug serum concentration
|
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
AUC0-t
Periodo de tiempo: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Area under the concentration-time curve from time zero (pre-dose) to the time of the dosing interval
|
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
AUC0-∞
Periodo de tiempo: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time
|
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
%AUCex
Periodo de tiempo: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Extrapolation percentage of AUC0-∞
|
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Tmax
Periodo de tiempo: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Time of occurrence of Cmax
|
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
T1/2
Periodo de tiempo: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Biological half life correlated with the elimination rate constant (kel) of semi-logarithmic concentration-time curve
|
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Vd
Periodo de tiempo: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Apparent volume of distribution
|
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
CL
Periodo de tiempo: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Clearance
|
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
λz
Periodo de tiempo: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Elimination rate constant
|
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hua Fang li, MD, Shanghai Mental Health Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NH101-11
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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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