Um Estudo Comparativo de Fase 1 para Avaliar a Farmacocinética, Imunogenicidade, Segurança e Tolerabilidade do Bmab3000 e do Herceptin Hylecta® Após uma Única Injeção Subcutânea de 600 mg em Voluntários Masculinos Saudáveis
Um Estudo Comparativo de Fase 1, Randomizado, Duplo-cego, com Dois Braços, Desenho Paralelo, para Avaliar a Farmacocinética, Imunogenicidade, Segurança e Tolerabilidade do Bmab3000 e do Herceptin Hylecta® Após uma Dose Única de 600 mg por Injeção Subcutânea em Voluntários Masculinos Saudáveis
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
-
-
Main Building: 264 Antigua Street,
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Christchurch, Main Building: 264 Antigua Street,, Nova Zelândia
- New Zealand Clinical Research (NZCR)
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 Ativo: 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 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Cmax
Prazo: Day 1 to Day 91
|
Maximum observed concentration (Cmax) of drug Bmab 3000 |
Day 1 to Day 91
|
|
AUCo-∞
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
AUCo-t
Prazo: 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
Prazo: Day 1 to Day 91
|
Time to maximum observed concentration |
Day 1 to Day 91
|
|
Vd/F
Prazo: Day 1 to Day 91
|
Volume of distribution |
Day 1 to Day 91
|
|
Cl/F
Prazo: Day 1 to Day 91
|
drug clearance |
Day 1 to Day 91
|
|
t1/2
Prazo: Day 1 to Day 91
|
Apparent terminal elimination half-life |
Day 1 to Day 91
|
|
AUC% extrapolation
Prazo: Day 1 to Day 91
|
% of the AUC that has been derived after extrapolation |
Day 1 to Day 91
|
|
λz
Prazo: Day 1 to Day 91
|
Elimination rate constant |
Day 1 to Day 91
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Safety_ Adverse Reactions
Prazo: Baseline to Day 91
|
Adverse Events and Adverse Reactions during the Treatment Period |
Baseline to Day 91
|
|
Safety_ Injection-site Reactions
Prazo: Day 1 to Day 91
|
Injection-site Reactions |
Day 1 to Day 91
|
|
Immunogenicity
Prazo: Day 1 to Day 91
|
Developing Antidrug Antibodies |
Day 1 to Day 91
|
|
Immunogenicity
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- BIO-TRASTU-103
- U1111-1329-7865 (Outro identificador: World Health Organization (WHO))
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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