A Phase I Study of INT-210 Capsules in Healthy Adult Subjects (INT-210-I101) (INT-210-I101)
27 de mayo de 2026 actualizado por: Innatus Therapeutics (Shanghai) Co., Ltd.
A Phase I, Single and Multiple Ascending Dose Escalation, and Food-Effect Study of the Safety, Tolerability and Pharmacokinetics of INT-210 Capsules in Healthy Adult Subjects
A Phase Ⅰ, Single and Multiple Ascending Dose escalation, and Food-Effect Study of the Safety, Tolerability and Pharmacokinetics of INT-210 Capsules in Healthy Adult Voluteers.
Primary Objectives:
● To assess the safety and tolerability of single and multiple oral dose of INT-210 capsules in healthy adult voluteers,
Secondary Objectives:
- To assess the pharmacokinetic(PK) profile of single and multiple oral doses of INT-210 capsules in healthy adult voluteers;
- To assess the safety and tolerability of INT-210 capsulese administered under fasting and fed(high-fat-meal) conditions in healthy adult voluteers;
- To assess the effect of food on the PK profile of a single oral dose of INT-210 capsules in healthy adult voluteers;
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
86
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
-
-
-
Beijing, Porcelana
- Beijing Municipality - Beijing Municipality - No. 101, Luyuan East Road, Tongzhou District, Beijing
-
-
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
Sí
Descripción
Inclusion Criteria:
- Male or female healthy voluteers
- Aged 18-45 years(inclusive),
- In good general health with no evidence of active or chronic disease; and who agree to comply with the prescribed contraceptive requirement during the trial and for 3 months after the last dose.
Exclusion Criteria:
- Female who are pregnant or breastfeeding; or planing pregnancy, female of chidbearing potential not using adequate contraception.
- Pre-existing significant medical conditions(cardiac, hepatic, renal, gastrointestina, etc), abnormal lab results, active infection, or history of special conditions like long QT syndrome or hypocalcemia.
- Positive screening for HIV, Hepatitis B/C or syphilis;
- Recent subject in another clinical trial;
- Recent major surgery, or significant blood loss.
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: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Single Ascending Dose from 50 mg to 800 mg
Single Ascending Dose
|
400 mg INT-210; Oral administration
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
|
|
Experimental: Food Effect: 400mg
|
400 mg INT-210; Oral administration
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
|
|
Experimental: Multiple Ascending Dose: 200 mg to 600mg
BID
|
400 mg INT-210; Oral administration
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
|
|
Comparador de placebos: Placebo
Placebo for SAD, MAD and Food Effect
|
INT-210 Placebo BID
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The incidence of treatment-emergent adverse events
Periodo de tiempo: From Day 1 through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
Number of participants with treatment-related adverse events as assessed.
The incidence of treatment-emergent adverse events will be measured using a combination of data collection methods, including tracking adverse events and assessing their onset or worsening relative to the initiation of treatment.
The most recent version of the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms will be used to classify adverse events, including their relationship to the treatment and maximum severity.
|
From Day 1 through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
|
Treatment-emergent potentially clinically- significant abnormalities in safety laboratory parameters-hematology
Periodo de tiempo: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
Hemoglobin, Hematocrit, Erythrocytes, Mean corpuscular volume, Platelets, Leukocytes, Eosinophils, Basophils, Neutrophils, Lymphocytes, Monocytes
|
From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
|
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: coagulation
Periodo de tiempo: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
Activated partial thromboplastin time, Prothrombin time, International Normalized Ratio, Fibrinogen
|
From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
|
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: serum chemistry
Periodo de tiempo: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
Glucose, Blood urea nitrogen, Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium, Bicarbonate, Phosphate, Bilirubin, total and direct, Alkaline phosphatase, Aspartate transaminase (=SGOT), Alanine transaminase (=SGPT), Gamma glutamyl transferase, Total protein, Albumin, Creatine kinase, Lactate dehydrogenase (LDH)
|
From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
|
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: urinalysis
Periodo de tiempo: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
Specific gravity, PH, Glucose, Protein, Nitrite , Urobilinogen, Occult Blood, White blood cells, Ketones, Red blood cells
|
From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
|
Treatment-emergent potentially clinically significant abnormalities in electrocardiogram values: QTcF (milliseconds)
Periodo de tiempo: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
ECG assessment (QTcF) as determined by the Investigator/consulting board-certified cardiologist
|
From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
|
Treatment-emergent potentially clinically significant abnormalities in vital signs: heart rate (beats per minute)
Periodo de tiempo: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
|
|
Treatment-emergent potentially clinically significant abnormalities in vital signs: blood pressure (mmHg)
Periodo de tiempo: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
|
|
Treatment-emergent potentially clinically significant abnormalities in vital signs: respiration rate (BPM)
Periodo de tiempo: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
|
|
Treatment-emergent potentially clinically significant abnormalities in vital signs: hemoglobin saturation (%)
Periodo de tiempo: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
|
|
Treatment-emergent potentially clinically significant abnormalities in vital signs: temperature (℃)
Periodo de tiempo: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pharmacokinetics parameter: Cmax of INT-210
Periodo de tiempo: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
Maximum observed plasma concentration (ng/mL)
|
SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
|
Pharmacokinetics parameter: Tmax of INT-210
Periodo de tiempo: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
Time of maximum observed concentration (Tmax) of INT-210
|
SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
|
Pharmacokinetics parameter: AUC (0-T) of INT-210
Periodo de tiempo: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
Area Under the concentration-time curve from dosing to the time of the last measured concentration (AUC0-T) (h*ng/L) of INT-210
|
SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
|
Pharmacokinetics parameter: T1/2 of INT-210
Periodo de tiempo: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
Half-life (T1/2) (hours) of INT-210
|
SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
|
Pharmacokinetics parameter: CL/F of INT-210
Periodo de tiempo: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
Apparent clearance (L/h) of INT-210
|
SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
|
Pharmacokinetics parameter: Vz/F of INT-210
Periodo de tiempo: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
Apparent volume of distribution (L) of INT-210
|
SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
|
Pharmacokinetics parameter: AUCinf of INT-210
Periodo de tiempo: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
Area under the curve from time 0 extrapolated to infinite time (AUCinf) (h*ng/L) of INT-210
|
SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Potential risk of QT/QTc interval prolongation of INT-210
Periodo de tiempo: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
A correlation model will be constructed using drug concentrations and ECG parameters to analyze the concentration-QTc relationship, and the potential risk of QT/QTc interval prolongation will be assessed by establishing a "concentration-effect model".
|
SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
|
Fraction excreted: Fraction of drug excreted unchanged in urine and Feces
Periodo de tiempo: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
Fraction of dose excreted unchanged into urine and feces as a percentage (%)
|
SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
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)
4 de septiembre de 2025
Finalización primaria (Actual)
6 de enero de 2026
Finalización del estudio (Actual)
6 de enero de 2026
Fechas de registro del estudio
Enviado por primera vez
24 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
27 de mayo de 2026
Publicado por primera vez (Actual)
1 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- INT-210-I101
- CTR20253467 (Otro identificador: National Medical Products Administration (NMPA))
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. .