Un Estudio Comparativo de Fase 1 para Evaluar la Farmacocinética, Inmunogenicidad, Seguridad y Tolerabilidad de Bmab3000 y Herceptin Hylecta® Tras una Inyección SC Única de 600 mg en Voluntarios Varones Sanos
Un estudio de fase 1, aleatorizado, doble ciego, de dos brazos, diseño paralelo, comparativo para evaluar la farmacocinética, inmunogenicidad, seguridad y tolerabilidad de Bmab3000 y Herceptin Hylecta® tras una dosis única de 600 mg de inyección subcutánea en voluntarios varones sanos
This phase I study is to compare the pharmacokinetics (PK), immunogenicity, safety, and tolerability of Bmab3000 (test) and Herceptin Hylecta (reference) after a single subcutaneous (s.c.) dose in healthy male volunteers.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a Phase 1, randomized, double-blind, two-arm, parallel-group trial comparing the pharmacokinetics (PK), immunogenicity, safety, and tolerability of Bmab3000 (test) and Herceptin Hylecta (reference) after a single subcutaneous (s.c.) dose.
A total of 150 healthy male participants (75 per arm) will be enrolled to ensure 138 evaluable subjects. Participants will be randomized in 1:1 using stratified block randomization based on baseline body weight (≥50-≤75 kg and >75-≤100 kg).
Each participant will be involved in the study for approximately four months, which includes one screening visit, a 3-night inpatient stay, and 16 scheduled outpatient follow-up visits. Participants will attend a screening visit (Day -28 to Day -1) to confirm eligibility. This will include obtaining informed consent, medical history, physical examination, vital signs, biometric measurements, ECG, echocardiogram, and blood and urine tests, as well as drug and alcohol screening. Eligible participants will be admitted to the study site on Day -1 for pre-dose assessments to confirm continued eligibility. On Day 1, participants will receive a single subcutaneous injection of either Bmab3000 or Herceptin Hylecta. During the inpatient stay (Days -1 to 3), participants will undergo continuous safety monitoring, including regular vital signs, ECGs, injection site checks, and blood sampling for pharmacokinetic, safety, and immunogenicity assessments. After discharge, participants will return for outpatient visits till Day 85 for continued safety monitoring, blood sampling for pharmacokinetic and immunogenicity analyses, and ECGs and vital sign assessments. The final visit on Day 91 will include a full physical examination, echocardiogram, ECG and blood sampling for pharmacokinetic & immunogenicity analyses and final laboratory evaluations.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Main Building: 264 Antigua Street,
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Christchurch, Main Building: 264 Antigua Street,, Nueva Zelanda
- New Zealand Clinical Research (NZCR)
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Healthy male volunteers aged between 18 to 65 years; both inclusive.
- Body weight ≥50 kg and ≤100 kg with body mass index (BMI) between 18.5 and 30 kg/m2, both inclusive.
- Participants should have Left ventricular ejection fraction (LVEF) ≥55%.
- Male participants must be using an acceptable method of contraception for the entire duration of the trial, and for at least three months after the trial drug administration. Participants must refrain from fathering a child or donating sperm in the next three months following the last trial drug administration or undergoing vasectomy.
- All non-prescription medications must have been discontinued at least 14 days prior to dosing.
- All non-topical prescription medications must have been stopped at least 30 days prior to admission to the clinical research center.
- Absence of significant findings in the vital signs, 12 lead ECG, and clinical laboratory tests of blood and urine.
- Willing and able to sign the informed consent form (ICF).
Exclusion Criteria:
- History of previous exposure to trastuzumab.
- Presence of clinically significant medical history and clinically significant findings in the physical examination.
- Allergy or hypersensitivity to trastuzumab, other recombinant human or humanized antibodies, other related products, or any excipients/ ingredients (e.g. hyaluronidase).
- Sick sinus syndrome or known long QT syndrome (QTcF >450 msec).
- Pronounced sinus bradycardia (<40 bpm), even if elicited by sport.
- History of relevant drug and/or food allergies.
- Positive urine drug and breath alcohol screen.
- Consumption of any foods containing poppy seeds within 48 hours (2 days) prior to screening/admission to the clinical research center.
- Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis virus (HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 and 2 antibodies.
- Donation or loss of blood prior to drug administration.
Plan de estudios
¿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 |
|---|---|
|
Experimental: Bmab3000
Single s.c. dose of Bmab3000 containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL |
Single s.c. dose of Herceptin Hylecta containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL |
|
Comparador activo: Herceptin Hylecta®
Single s.c. dose of Herceptin Hylecta containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL |
Single s.c. dose of Bmab3000 containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cmax
Periodo de tiempo: Day 1 to Day 91
|
Maximum observed concentration (Cmax) of drug Bmab 3000 |
Day 1 to Day 91
|
|
AUCo-∞
Periodo de tiempo: Day 1 to Day 91
|
Comparison of area under the concentration-time curve from time 0 to infinity (AUC0-inf) |
Day 1 to Day 91
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
AUCo-t
Periodo de tiempo: Day 1 to Day 91
|
Area Under the serum Concentration versus time curve from time 0 to the last sampling time at which concentrations were at or above the limit of quantification |
Day 1 to Day 91
|
|
Tmax
Periodo de tiempo: Day 1 to Day 91
|
Time to maximum observed concentration |
Day 1 to Day 91
|
|
Vd/F
Periodo de tiempo: Day 1 to Day 91
|
Volume of distribution |
Day 1 to Day 91
|
|
Cl/F
Periodo de tiempo: Day 1 to Day 91
|
drug clearance |
Day 1 to Day 91
|
|
t1/2
Periodo de tiempo: Day 1 to Day 91
|
Apparent terminal elimination half-life |
Day 1 to Day 91
|
|
AUC% extrapolation
Periodo de tiempo: Day 1 to Day 91
|
% of the AUC that has been derived after extrapolation |
Day 1 to Day 91
|
|
λz
Periodo de tiempo: Day 1 to Day 91
|
Elimination rate constant |
Day 1 to Day 91
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Safety_ Adverse Reactions
Periodo de tiempo: Baseline to Day 91
|
Adverse Events and Adverse Reactions during the Treatment Period |
Baseline to Day 91
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|
Safety_ Injection-site Reactions
Periodo de tiempo: Day 1 to Day 91
|
Injection-site Reactions |
Day 1 to Day 91
|
|
Immunogenicity
Periodo de tiempo: Day 1 to Day 91
|
Developing Antidrug Antibodies |
Day 1 to Day 91
|
|
Immunogenicity
Periodo de tiempo: Day 1 to Day 91
|
Developing Neutralizing Antibodies |
Day 1 to Day 91
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Dr Cory Sellwood, MBBS, New Zealand Clinical Research (NZCR) Main Building: 264 Antigua Street, Christchurch, New Zealand
- Investigador principal: Dr Leanne Barnett, MBBS, New Zealand Clinical Research (NZCR) Main Building: 3 Ferncroft Street, Grafton, Auckland, New Zealand
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- BIO-TRASTU-103
- U1111-1329-7865 (Otro identificador: World Health Organization (WHO))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
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