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- Ensaio Clínico NCT07612813
A Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adults
A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adult Participants
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This is a Phase I, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety and PK of AZD7760, a mAb combination of suvratoxumab (labeled as MEDI4893) and AZD7745, in healthy Japanese adults. Two dosages of AZD7760 each administered as a single IV dose, will be assessed.
Study details include:
- A Screening Period of up to 28 days.
- A Dosing Period of 3 days, in which a single IV infusion will be given on Day 1.
- A Follow-up Period of 12 months from the time of administration of the study intervention.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: AstraZeneca Clinical Study Information Center
- Número de telefone: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Locais de estudo
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Sumida-ku, Japão, 130-0004
- Recrutamento
- Research Site
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Body weight ≥ 45 kg and ≤ 110 kg and BMI within the range of ≥ 18.0 to ≤ 30.0 kg/m2 (inclusive) at screening.
- Healthy Japanese participants with no clinically significant concomitant diseases or medications.
Exclusion Criteria:
- Known hypersensitivity to any component of the study intervention.
- Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of mAbs.
- Clinically significant bleeding disorder or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.
- AST or ALT above 1.5 × ULN at screening.
- Estimated glomerular filtration rate < 90 mL/min/1.73 m2.
- Hemoglobin or platelet count below the lower limit of normal at screening.
- White blood cell counts outside normal reference ranges.
- History of malignancy other than treated non-melanoma skin cancers or locally treated cervical cancer in the previous 5 years.
- Any clinically significant abnormalities on 12-lead ECG at screening,
- Acute (time-limited) illness, including fever ≥ 38 °C (100.4 °F), one day prior to or on the day of planned dosing.
- Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy.
- Any condition that has the potential to increase clearance of the study intervention.
Blood donation or collection as follows:
- 400 mL whole blood donation within 12 weeks (males) or 16 weeks (females) prior to study drug administration.
- 200 mL whole blood donation within 4 weeks prior to study drug administration.
- Apheresis donation within 2 weeks prior to study drug administration.
- Absence of suitable veins for blood sampling and administration of study intervention.
- Any other condition that would compromise the safety of the participants.
- Any condition that might interfere with evaluation of the study intervention or interpretation of participant safety or study results.
- Any laboratory value in the screening panel that, in the opinion of the investigator, is clinically significant or might confound analysis of study results. Testing may be repeated once at the investigator's discretion.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Cohort 1 (AZD7760 Dose A)
Participants receive an IV infusion of AZD7760 Dose A on Day 1.
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Participants will receive AZD7760 via IV infusion.
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Experimental: Cohort 2 (AZD7760 Dose B)
Participants receive an IV infusion of AZD7760 Dose B on Day 1.
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Participants will receive AZD7760 via IV infusion.
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Comparador de Placebo: Pooled Placebo
Participants receive an IV infusion of matching placebo on Day 1.
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Participants will receive matching placebo via IV infusion.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Occurrence of Adverse Events (AEs)
Prazo: Day 1 to Day 181
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To evaluate the safety of AZD7760 administered as a single IV Dose A or Dose B in healthy Japanese adult participants.
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Day 1 to Day 181
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Occurrence of Medically-attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Prazo: Day 1 to Day 361
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To evaluate the safety of AZD7760 administered as a single IV Dose A or Dose B in healthy Japanese adult participants.
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Day 1 to Day 361
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Maximum observed serum (peak) drug concentration (Cmax)
Prazo: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
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Day 1 to Day 361
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Time to reach peak or maximum observed concentration following drug administration (tmax)
Prazo: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
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Day 1 to Day 361
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Terminal elimination half-life (t½λz)
Prazo: Day 1 to Day 361
|
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
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Day 1 to Day 361
|
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Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast)
Prazo: Day 1 to Day 361
|
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
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Day 1 to Day 361
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Area under the concentration-time curve from time 0 to infinity (AUCinf)
Prazo: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
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Day 1 to Day 361
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Volume of distribution at steady state (Vss)
Prazo: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
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Day 1 to Day 361
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Volume of distribution based on the terminal phase (Vz)
Prazo: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
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Day 1 to Day 361
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Incidence of Anti-drug antibody (ADA)
Prazo: Day 1 to Day 361
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To evaluate ADA responses to AZD7760 in serum of healthy Japanese adult participants
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Day 1 to Day 361
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
- D7480C00003
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
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