A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants
23 de junio de 2026 actualizado por: Shanghai Argo Biopharmaceutical Co., Ltd.
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of A Single Dose of BW-50218 in Healthy Chinese Participants
A Phase 1 Study of Single-Dose BW-50218 in Healthy Chinese Participants
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of A Single Dose of BW-50218 in Healthy Chinese Participants
Tipo de estudio
Intervencionista
Inscripción (Estimado)
24
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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Shanghai, Porcelana
- Argo Investigative Site
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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
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Capable of providing written informed consent and complying with all study procedures for the duration of the study.
- Body weight > 50 kg for males and > 45 kg for females; body mass index (BMI) within a range considered appropriate for study participation by the investigator.
- Female participants must be non-pregnant, non-lactating, and either of non-childbearing potential or using highly effective contraception.
- Male participants with partners of childbearing potential must agree to use effective contraception.
Exclusion Criteria:
- Any clinically significant chronic medical condition or clinically significant abnormality in physical examination that, in the opinion of the Investigator, makes the participant unsuitable for participation in the study.
- Recent hospitalization or a significant acute medical event.
- History of cancer or any long-term medical condition that the study doctor considers clinically relevant.
- Clinical laboratory findings outside of range which are deemed clinically significant by the investigator at screening or Day -1.
- Positive test for hepatitis B, hepatitis C, or HIV.
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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Comparador de placebos: Placebo salino
Dosis única de Placebo Salino
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Solución inyectable
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Experimental: BW-50218 Dose1
Single dose of BW-50218 injection (Dose 1)
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Solución inyectable
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Experimental: BW-50218 Dose 2
Single dose of BW-50218 injection (Dose 2)
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Solución inyectable
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Experimental: BW-50218 Dose 3
Single dose of BW-50218 injection (Dose 3)
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Solución inyectable
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAES)
Periodo de tiempo: From baseline up to Day 360 (End of Study)
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Evaluation of the number of participants with treatment-emergent adverse events and serious adverse events.
The severity of AEs will be assessed and categorized according to the "Guidance for industry: Toxicity Grading Scale for Healthy Adultand Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" (FDA, 2007).
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From baseline up to Day 360 (End of Study)
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Hematology results (Platelets, 10^9/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.
Periodo de tiempo: From baseline up to Day 360 (End of Study)
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The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety.
Those values or changes in values that are identified as being clinically significant will be flagged.
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From baseline up to Day 360 (End of Study)
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Hematology results (concentration of Hemoglobin, g/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.
Periodo de tiempo: From baseline up to Day 360 (End of Study)
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The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety.
Those values or changes in values that are identified as being clinically significant will be flagged.
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From baseline up to Day 360 (End of Study)
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Chemistry results (Albumin, g/L) at each time point from baseline to Day 360 will be summarized bytreatment group.
Periodo de tiempo: From baseline up to Day 360 (End of Study)
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The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety.
Those values or changes in values that are identified as being clinically significant will be flagged.
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From baseline up to Day 360 (End of Study)
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Chemistry results (Alkaline Phosphatase, U/L; Alanine Aminotransferase, U/L; Aspartate Aminotransferase, U/L) at each time point from baseline to Day 360 will be summarized bytreatment group.
Periodo de tiempo: From baseline up to Day 360 (End of Study)
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The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety.
Those values or changes in values that are identified as being clinically significant will be flagged.
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From baseline up to Day 360 (End of Study)
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Chemistry results (Direct Bilirubin, umol/L) at each time point from baseline to Day 360 will be summarized bytreatment group.
Periodo de tiempo: From baseline up to Day 360 (End of Study)
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The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety.
Those values or changes in values that are identified as being clinically significant will be flagged.
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From baseline up to Day 360 (End of Study)
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Urinalysis results (Epithelial cells, crystals, casts, bilirubin) at each time point,including change from baseline to Day 360 post dose will be summarized in thetable by treatment group.
Periodo de tiempo: From baseline up to Day 360 (End of Study)
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The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety.
Those values or changes in values that are identified as being clinically significant will be fagged.
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From baseline up to Day 360 (End of Study)
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Vital signs (Blood pressures, millimeters of mercury) changes from Baselinevalues to Day 360 post dose will be summarized in the table by treatment group
Periodo de tiempo: From baseline up to Day 360 (End of Study)
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Abnormal physical examination findings will be listed.
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From baseline up to Day 360 (End of Study)
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Vital signs (Heart rate, beats per minute) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.
Periodo de tiempo: From baseline up to Day 360 (End of Study)
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Abnormal physical examination findings will be listed.
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From baseline up to Day 360 (End of Study)
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Vital signs (Respiratory rate, times per minute) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.
Periodo de tiempo: From baseline up to Day 360 (End of Study)
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Abnormal physical examination findings will be listed.
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From baseline up to Day 360 (End of Study)
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Vital signs (Temperature,degrees Celsius) changes from Baseline values to Day 360 post dose will be summarized in the table by treatment group.
Periodo de tiempo: From baseline up to Day 360 (End of Study)
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Abnormal physical examination findings will be listed.
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From baseline up to Day 360 (End of Study)
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Changes in ECG (PR Interval, msec; QRs Duration, msec;QT interval, msec; RR interval, msec; QTcF Interval, msec; ) from Baseline to Day 360 post-dose will be summarized.
Periodo de tiempo: From baseline up to Day 360 (End of Study)
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12-lead ECGs will be summarized by visit and by treatment group, along with the changes from baseline.The summary of overall interpretation findings table presented counts and percentages for the reported results at Baseline and Day 360/time point.
Result categories were ordered as "Normal", "Abnormal Not Clinically Significant (NCS)" and "Abnormal Clinically Significant (CS)"(categorical descriptive analysis).
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From baseline up to Day 360 (End of Study)
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Changes in ECG (Mean heart rate, bpm ) from Baseline to Day 360 post-dose will be summarized.
Periodo de tiempo: From baseline up to Day 360 (End of Study)
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12-lead ECGs will be summarized by visit and by treatment group, along with the changes from baseline.The summary of overall interpretation findings table presented counts and percentages for the reported results at Baseline and Day 360/time point.
Result categories were ordered as "Normal", "Abnormal Not Clinically Significant (NCS)" and "Abnormal Clinically Significant (CS)"(categorical descriptive analysis).
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From baseline up to Day 360 (End of Study)
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Change from Baseline in Physical Examination Findings
Periodo de tiempo: From baseline up to Day 360 (End of Study)
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Assessment of clinically significant changes in physical examination findings
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From baseline up to Day 360 (End of Study)
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Hematology results (Red blood cell count, 10^12/L) at each time point, including changes from baseline to Day 360 post dose will be summarized by treatment group.
Periodo de tiempo: From baseline up to Day 360 (End of Study)
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The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
The values that are below the lower limit or above the upper limit ofthe reference range will be flagged for safety.
Those values or changes in values that are identified as being clinically significant will be flagged.
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From baseline up to Day 360 (End of Study)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Concentración plasmática máxima observada (Cmax)
Periodo de tiempo: Desde la predosis hasta el Día 8
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Evaluación de la concentración plasmática máxima de BW-50218.
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Desde la predosis hasta el Día 8
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Tiempo para la Concentración Plasmática Máxima (Tmax)
Periodo de tiempo: Desde antes de la dosis hasta el Día 8
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Evaluación del tiempo para alcanzar la concentración plasmática máxima.
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Desde antes de la dosis hasta el Día 8
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Area Under the Plasma Concentration-Time Curve (AUC)
Periodo de tiempo: From pre-dose up to Day 8
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Evaluation of AUc from time zero to 24 hours (AUC0-24), to 48 hours (AUC0-48), and to infinity (AUC0-inf)
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From pre-dose up to Day 8
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Terminal Elimination Half-Life (t1/2)
Periodo de tiempo: From pre-dose up to Day 8
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Evaluation of the elimination half-life of BW-50218
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From pre-dose up to Day 8
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Urine Pharmacokinetic Parameters (Renal Clearance, CLr)
Periodo de tiempo: From pre-dose up to 24 hours post-dose
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Renal clearance calculated as CLr = CAe/Plasma AUC 0-24.
Ae=cumulative amount excreted in urine (mg).
AUC 0-24 = Area under the plasma concentration - time curve from 0 to 24 hours(e.g.mg*h/mL)
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From pre-dose up to 24 hours post-dose
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Yuqiong Li, Shanghai Argo Biopharmaceutical Co., Ltd.
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)
18 de mayo de 2026
Finalización primaria (Estimado)
30 de junio de 2027
Finalización del estudio (Estimado)
30 de abril de 2028
Fechas de registro del estudio
Enviado por primera vez
13 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de mayo de 2026
Publicado por primera vez (Actual)
11 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
23 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BW-50218-1002
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
A decision regarding sharing of de-identified IPD will be made by the Sponsor after study completion and will consider scientific merit, participant privacy, and regulatory requirements.
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
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