Seguridad, farmacocinética y efecto alimentario de PS1 en sujetos sanos
2 de julio de 2026 actualizado por: Pharmasaga Co. Ltd.
Estudio de fase I, doble ciego, controlado con placebo, aleatorizado, de dosis única y múltiple ascendente para evaluar la seguridad, la tolerabilidad, la farmacocinética y el efecto alimentario de PS1 en sujetos sanos
Este es un estudio de fase I, doble ciego, controlado con placebo, aleatorizado, de dosis única y múltiple ascendente para evaluar la nueva intervención del estudio, PS1.
PS1 es un medicamento potencial para el control de la glucosa en sangre, desarrollado por Pharmasaga Co. Ltd. previsto para el tratamiento de la diabetes mellitus tipo II (T2DM).
Este es el primer estudio en humanos para evaluar la seguridad, la tolerabilidad, la farmacocinética (PK) y el efecto alimentario de PS1 en sujetos sanos.
Descripción general del estudio
Descripción detallada
Este primer estudio de fase I en humanos consta de una porción de dosis única ascendente (SAD), una porción de efecto alimentario (FE) y una porción de dosis ascendente múltiple (MAD), con el objetivo de evaluar la seguridad, tolerabilidad, farmacocinética, y el efecto alimentario de PS1 en sujetos sanos.
Se aplicará un diseño de estudio aleatorizado, doble ciego, controlado con placebo para la porción de SAD con tres cohortes de dosis de SAD: 100 mg (cohorte 1), 200 mg (cohorte 2) y 400 mg (cohorte 3). Un sujeto elegible en esta porción recibirá una dosis única de tabletas de PS1 o Placebo en una condición de alimentación el Día 1 y se le dará seguimiento durante 14 días.
En la porción FE, solo se asigna una cohorte (Cohorte 4). La cohorte FE (cohorte 4) utilizará el mismo diseño de estudio que las cohortes SAD. Un sujeto elegible en esta porción recibirá una dosis única de 100 mg de PS1 o tabletas de placebo en ayunas el día 1 y se le dará seguimiento durante 14 días.
Se asignan dos cohortes en la porción de MAD: 50 mg/día (Cohorte 5) y 100 mg/día (Cohorte 6). Solo se puede activar el nivel de dosis de MAD inferior a la dosis máxima tolerada (MTD) de la porción SAD (si se determinaron 100 mg como la MTD de SAD, solo se podría activar la cohorte 5). Un sujeto elegible recibirá tabletas de PS1 o Placebo una vez al día con alimentación durante 28 días y se le dará seguimiento durante 14 días adicionales.
Tipo de estudio
Intervencionista
Inscripción (Actual)
75
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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Taipei, Taiwán
- Mingche Liu
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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
20 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Descripción
Criterios de inclusión:
- Ambos sexos de 20 a 80 años, inclusive en el momento de la selección
- Sujeto manifiestamente sano, que se considera generalmente sano según el historial médico, los signos vitales, las pruebas de laboratorio, el electrocardiograma de 12 derivaciones y el examen físico, a juicio del investigador.
- Con valor de HbA1c de < 6,5 % en la selección
- Glucosa plasmática en ayunas < 110 mg/dl en la selección
- Índice de masa corporal (IMC) entre 18,5 y 28,0 kg/m2
- Prueba negativa para antígeno de superficie de hepatitis B (HBsAg), anticuerpo anti-VHC o virus de inmunodeficiencia humana (VIH) en la selección
- Está dispuesto a cumplir con las restricciones del ensayo.
- Capaz de entender y firmar el formulario de consentimiento informado
Criterio de exclusión:
- Historia de diabetes mellitus
- Bajo el tratamiento sistémico de cualquier medicamento recetado o de venta libre (OTC) dentro de los 7 días antes de la selección
- Recibió alguna vacuna dentro de los 14 días antes de la selección
- Hipersensibilidad conocida a cualquiera de los componentes de la tableta PS1
- Antecedentes de enfermedades hematológicas, renales, endocrinas, pulmonares, respiratorias, gastrointestinales, cardiovasculares, hepáticas, psiquiátricas, neurológicas, musculoesqueléticas, inmunitarias o alérgicas clínicamente significativas (incluidas las alergias a medicamentos, pero excluyendo las alergias estacionales, asintomáticas y no tratadas en el momento de la dosificación) dentro de los 3 meses posteriores a la selección que puede alterar significativamente el panel de biomarcadores, requerir recibir algún medicamento sistémico o interferir con la interpretación de los datos, según lo juzgue el investigador
- Antecedentes de cáncer (malignidad) o alguna vez ha recibido alguna terapia contra el cáncer
- fumador habitual
- Consumió más de 3 vasos de bebidas alcohólicas por día durante las últimas 4 semanas antes de la selección
- Recibió cualquier terapia de investigación de otro estudio clínico, realizó cirugías importantes o tomó medicamentos para reducir la glucosa en las últimas 12 semanas antes de la selección
- Recibió esteroides sistémicos (se permiten esteroides inhalados e intranasales) u otros medicamentos inmunosupresores dentro de las 4 semanas anteriores a la selección
- Ha recibido alguna vez terapia celular o trasplante de órganos
- Otras condiciones no adecuadas para participar en este estudio a juicio del investigador
- Cualquier condición que prohíba la realización de los procedimientos del estudio debido a las restricciones reglamentarias locales.
- Sujeto femenino en edad fértil que:
está lactando; o Tiene un resultado positivo en la prueba de embarazo al firmar el consentimiento informado hasta el final del estudio; o Se niega a adoptar al menos una forma de control de la natalidad (consulte la Sección 5.3) desde la firma del consentimiento informado hasta el final del estudio.
- El sujeto masculino con una esposa/pareja en edad fértil se niega a adoptar al menos una forma de control de la natalidad (consulte la Sección 5.3) desde la firma del consentimiento informado hasta el final del estudio.
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: SAD portion - Cohort 1 (25mg)
An eligible healthy subject will receive a single dose of 25 mg of PS1 or Placebo tablet in a fed condition on Day 1 and be followed for 7 days.
|
PS1 se proporcionará en forma de tableta de 120 mg con 25 mg de ingrediente farmacéutico activo.
Otros nombres:
El placebo se proporcionará en forma de tableta de 120 mg.
|
|
Experimental: SAD portion - Cohort 2 (50mg)
An eligible healthy subject will receive a single dose of 50 mg of PS1 or Placebo tablets in a fed condition on Day 1 and be followed for 7 days.
|
PS1 se proporcionará en forma de tableta de 120 mg con 25 mg de ingrediente farmacéutico activo.
Otros nombres:
El placebo se proporcionará en forma de tableta de 120 mg.
|
|
Experimental: SAD portion - Cohort 3 (75mg)
An eligible healthy subject will receive a single dose of 75 mg of PS1 or Placebo tablets in a fed condition on Day 1 and be followed for 7 days.
|
PS1 se proporcionará en forma de tableta de 120 mg con 25 mg de ingrediente farmacéutico activo.
Otros nombres:
El placebo se proporcionará en forma de tableta de 120 mg.
|
|
Experimental: FE portion - Cohort 4 (50mg)
An eligible healthy subject will receive a single dose of 50 mg PS1 or Placebo tablets in a fasted condition on Day 1 and be followed for 7 days.
|
PS1 se proporcionará en forma de tableta de 120 mg con 25 mg de ingrediente farmacéutico activo.
Otros nombres:
El placebo se proporcionará en forma de tableta de 120 mg.
|
|
Experimental: SAD portion - Cohort A (25mg)
An eligible T2DM subject will receive 25 mg PS1 tablet once daily in a fed condition for 1 day and be followed for additional 14 days.
|
PS1 se proporcionará en forma de tableta de 120 mg con 25 mg de ingrediente farmacéutico activo.
Otros nombres:
El placebo se proporcionará en forma de tableta de 120 mg.
|
|
Experimental: SAD portion - Cohort B (50mg)
An eligible T2DM subject will receive 50 mg PS1 tablets once daily in a fed condition for 1 day and be followed for additional 14 days.
|
PS1 se proporcionará en forma de tableta de 120 mg con 25 mg de ingrediente farmacéutico activo.
Otros nombres:
El placebo se proporcionará en forma de tableta de 120 mg.
|
|
Experimental: MAD portion - Cohort 7 (25mg)
An eligible subject will receive 25 mg PS1 or Placebo tablet once daily in a fed condition for 28±1 days and be followed for additional 7 days.
|
PS1 se proporcionará en forma de tableta de 120 mg con 25 mg de ingrediente farmacéutico activo.
Otros nombres:
El placebo se proporcionará en forma de tableta de 120 mg.
|
|
Experimental: MAD portion - Cohort 8 (50mg)
An eligible subject will receive 50 mg PS1 or Placebo tablets once daily in a fed condition for 28±1 days and be followed for additional 7 days.
|
PS1 se proporcionará en forma de tableta de 120 mg con 25 mg de ingrediente farmacéutico activo.
Otros nombres:
El placebo se proporcionará en forma de tableta de 120 mg.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of dose-limiting toxicity (DLT) during the DLT observation period and the maximum tolerated dose (MTD) of PS1
Periodo de tiempo: DLT observation period: from Day 1 to EOS - For SAD and FE cohorts in healthy subjects: from Day 1 to Day 8±1 - For MAD cohorts in T2DM patients: from Day 1 to Day 35±1
|
Dose escalation will be terminated based on the following criteria: - Among the six subjects who received PS1 in a cohort, more than one subject experienced DLT(s). MTD will basically be declared as the highest dose level at which ≤1/6 of PS1-treated subjects in a cohort experienced DLT(s). DLT is defined as
that occurs in the DLT observation period and is causally related (possibly, probably, or definitely related) to the test article judged by the investigator. |
DLT observation period: from Day 1 to EOS - For SAD and FE cohorts in healthy subjects: from Day 1 to Day 8±1 - For MAD cohorts in T2DM patients: from Day 1 to Day 35±1
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of adverse events (AEs) and serious adverse events (SAEs)
Periodo de tiempo: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
All adverse events (AEs) will be assessed for severity by the investigator based on NCI-CTCAE v5.0
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SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
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Changes in vital signs (Systolic Blood Pressure & Diastolic Blood Pressure) at each post-treatment measurement from baseline
Periodo de tiempo: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Vital signs (Systolic Blood Pressure & Diastolic Blood Pressure)(Unit: mmHg)
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
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Changes in Laboratory examinations - Hematology (Hemoglobin and mean corpuscular hemoglobin concentration, MCHC) at each post-treatment measurement from baseline
Periodo de tiempo: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Number of participants with abnormal laboratory - Hematology physiological parameter tests results (Hemoglobin and mean corpuscular hemoglobin concentration, MCHC) (Unit: g/dL)
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
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Changes in acute kidney injury (AKI)-NGAL markers at each post-treatment measurement from baseline
Periodo de tiempo: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Urine samples will be collected for analyzing acute kidney injury (AKI) markers, NGAL.
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SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
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Changes in 12-lead electrocardiogram (EKG) (PR interval, QRS interval, and QT interval) at each post-treatment measurement from baseline
Periodo de tiempo: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
PR interval, QRS interval, and QT interval will be recorded.
[Unit: msec]
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SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
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Abnormalities in Physical examination
Periodo de tiempo: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Number of participants with abnormal Physical examination findings, including general appearance, skin, eyes, ears, nose, throat, head and neck (including thyroid), heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal, neurological system, and other body systems
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SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
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Pharmacokinetics (PK) of PS1
Periodo de tiempo: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
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AUC_Area under the serum concentration-time profile
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Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
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Pharmacokinetics (PK) of PS1
Periodo de tiempo: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
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Cmax_The peak post-dose concentration
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Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
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Pharmacokinetics (PK) of PS1
Periodo de tiempo: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
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Tmax_Time at which Cmax is observed
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Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
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Pharmacokinetics (PK) of PS1
Periodo de tiempo: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
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T1/2_Terminal phase elimination half-life
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Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
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Pharmacokinetics (PK) of PS1
Periodo de tiempo: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
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MRT_Mean Residence Time
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Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
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Pharmacokinetics (PK) of PS1
Periodo de tiempo: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
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CL/F_Apparent Clearance
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Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
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Pharmacokinetics (PK) of PS1
Periodo de tiempo: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
|
Volume of distribution
|
Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
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Pharmacokinetics (PK) of PS1
Periodo de tiempo: Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
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Rac_Accumulation ratio
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Day 1 and 2 (SAD, FE in healthy volunteers and SAD in T2DM subjects and MAD portion in T2DM subjects ), Day 28 and 29 (MAD portion only)
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Potential efficacy (For Cohort 7 and 8 only)
Periodo de tiempo: MAD in T2DM subjects: Approximately 7 weeks
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Changes from baseline of fasting plasma glucose (FPG) at each post-treatment visit; Changes from baseline of C-peptide at each post-treatment visit; Changes from baseline of hemoglobin A1c (HbA1c) at Visit 10 and Visit 11.
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MAD in T2DM subjects: Approximately 7 weeks
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Changes from baseline of postprandial plasma glucose (PPG), at each post-treatment visit in T2DM patients
Periodo de tiempo: SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
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Postprandial plasma glucose (PPG) data.
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SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
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Changes from baseline of postprandial serum insulin (PSI) at each post-treatment visit in T2DM patients
Periodo de tiempo: SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
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Postprandial serum insulin (PSI) data.
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SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
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Changes from baseline of fasting serum insulin (FSI) at each post-treatment visit in T2DM patients
Periodo de tiempo: SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
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Fasting serum insulin (FSI) data.
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SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
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Changes in acute kidney injury (AKI)-KIM-1 markers at each post-treatment measurement from baseline
Periodo de tiempo: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Urine samples will be collected for analyzing acute kidney injury (AKI) markers, KIM-1.
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SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
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Changes in Laboratory examinations - Biochemistry at each post-treatment measurement from baseline
Periodo de tiempo: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Number of participants with abnormal laboratory - Biochemistry physiological parameter tests results
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SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
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Changes in Laboratory examinations - Urinalysis at each post-treatment measurement from baseline
Periodo de tiempo: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Number of participants with abnormal laboratory - Urinalysis physiological parameter tests results
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
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Changes in vital signs (Pulse rate) at each post-treatment measurement from baseline
Periodo de tiempo: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Vital signs (Pulse rate) (Unit: beats/min)
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
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Changes in vital signs (Respiratory Rate) at each post-treatment measurement from baseline
Periodo de tiempo: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
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Vital signs (Respiratory Rate) (Unit: breaths/min)
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SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
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Changes in vital signs (Temperature) at each post-treatment measurement from baseline
Periodo de tiempo: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Vital signs (Temperature) (Unit: Celsius)
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SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
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Changes in Laboratory examinations - Hematology (hematocrit and WBC differentials (neutrophils, eosinophils, basophils, lymphocytes, monocytes)) at each post-treatment measurement from baseline
Periodo de tiempo: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Number of participants with abnormal laboratory - Hematology physiological parameter tests results (hematocrit and WBC differentials (neutrophils, eosinophils, basophils, lymphocytes, monocytes)) (Unit: %)
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SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
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Changes in Laboratory examinations - Hematology (RBC) at each post-treatment measurement from baseline
Periodo de tiempo: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Number of participants with abnormal laboratory - Hematology physiological parameter tests results (RBC) (Unit: 10^6/uL)
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
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Changes in Laboratory examinations - Hematology (platelet and WBC) at each post-treatment measurement from baseline
Periodo de tiempo: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Number of participants with abnormal laboratory - Hematology physiological parameter tests results (platelet and WBC) (Unit: 10^3/uL)
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
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Changes in Laboratory examinations - Hematology (mean corpuscular volume, MCV) at each post-treatment measurement from baseline
Periodo de tiempo: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Number of participants with abnormal laboratory - Hematology physiological parameter tests results (mean corpuscular volume, MCV) (Unit: fL)
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
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Changes in Laboratory examinations - Hematology (mean corpuscular hemoglobin, MCH) at each post-treatment measurement from baseline
Periodo de tiempo: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Number of participants with abnormal laboratory - Hematology physiological parameter tests results (mean corpuscular hemoglobin, MCH) (Unit: pg)
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
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Changes in 12-lead electrocardiogram (EKG) (Ventricular rate) at each post-treatment measurement from baseline
Periodo de tiempo: SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Ventricular rate will be recorded.
[Unit: beats/min]
|
SAD, FE in healthy volunteers: Approximately 3 weeks; SAD in T2DM subjects: Approximately 4 weeks; MAD in T2DM subjects: Approximately 7 weeks
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Exploratory Endpoints (For MAD only)
Periodo de tiempo: MAD in T2DM subjects: Approximately 7 weeks
|
Changes from baseline of serum PDIA4
|
MAD in T2DM subjects: Approximately 7 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Mingche Liu, MD., PhD, Taipei Medical University Hospital
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)
22 de diciembre de 2023
Finalización primaria (Actual)
27 de abril de 2026
Finalización del estudio (Actual)
5 de junio de 2026
Fechas de registro del estudio
Enviado por primera vez
29 de noviembre de 2021
Primero enviado que cumplió con los criterios de control de calidad
3 de enero de 2022
Publicado por primera vez (Actual)
4 de enero de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PS1-01
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.
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. .