- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02555085
Single Ascending Doses of BIIB063 in Healthy Volunteers
17 de abril de 2017 atualizado por: Biogen
Phase 1 Randomized, Blinded, Placebo-Controlled Study of Single Ascending Doses of BIIB063 in Healthy Volunteers
The primary objective of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) doses and a single subcutaneous (SC) dose of BIIB063 in healthy volunteers.
The secondary objectives of the study are to estimate the PK parameters of single ascending IV doses of BIIB063; to estimate the PK parameters and absolute bioavailability (F) of a single SC dose of BIIB063; and to evaluate the immunogenicity of single ascending doses of BIIB063.
Visão geral do estudo
Tipo de estudo
Intervencional
Inscrição (Real)
29
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
West Yorkshire
-
Leeds, West Yorkshire, Reino Unido, LD2 9LH
- Research Site
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 55 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Key Inclusion Criteria:
- All male subjects and all female subjects of childbearing potential must practice at least 1 highly effective method of contraception (i.e., contraceptive measure with a failure rate of <1% per year; estrogen-containing contraceptives are prohibited) during the study and be willing and able to continue contraception for 4 months after being dosed with study treatment. Male subjects must also be willing to refrain from sperm donation for at least 4 months after the last dose of study treatment. Male subjects must not have unprotected sexual intercourse with a female who is pregnant or breastfeeding during the study.
- Must have a body mass index between 18 and 30 kg/m2, inclusive.
- Must be in good health as determined by the Investigator, based on medical history, physical examination, and 12-lead ECG.
Key Exclusion Criteria:
- History of or positive test result at screening for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]).
- History of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator.
- Personal or family history of cardiovascular disease under the age of 50 years, inherited disorder of coagulation (e.g., Factor V Leiden, protein C or S deficiency), or anti-phospholipid Ab syndrome (APS).
- History of meningococcal vaccination or meningococcal meningitis, or history of hypersensitivity to single components of meningococcal vaccines (including MENVEO), any other CRM197, diphtheria toxoid, or meningococcal-containing vaccine.
- History of tuberculosis (TB) or positive QuantiFERON®-TB Gold test
- Personal history of thromboembolic events
- Treatment with any prescription or over-the-counter medication within 14 days prior to randomization (excluding vitamins, dietary supplements, herbal preparations, progestin-only birth control, and paracetamol up to 4 g/day for no more than 5 consecutive days).
- Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 3 months
- Current enrollment or a plan to enroll in any other drug, biologic or device clinical study, or treatment with an investigational drug or approved therapy for investigational use within 3 months
- Blood donation (1 unit or more) within 3 months prior to randomization.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: IV Dose 1
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
|
Single ascending IV dose
Dose única
|
Experimental: IV Dose 2
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
|
Single ascending IV dose
Dose única
|
Experimental: IV Dose 3
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
|
Single ascending IV dose
Dose única
|
Experimental: IV Dose 4
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
|
Single ascending IV dose
Dose única
|
Experimental: IV Dose 5
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
|
Single ascending IV dose
Dose única
|
Experimental: IV Dose 6
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
|
Single ascending IV dose
Dose única
|
Experimental: IV Dose 7
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
|
Single ascending IV dose
Dose única
|
Experimental: SC Dose
Single SC dose or matching placebo
|
Single ascending IV dose
Dose única
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Prazo: Up to week 12
|
Up to week 12
|
Number of participants with clinically significant laboratory assessment abnormalities
Prazo: Up to week 12
|
Up to week 12
|
Number of participants with clinically significant Vital sign abnormalities
Prazo: Up to week 12
|
Up to week 12
|
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Prazo: Up to week 12
|
Up to week 12
|
Number of participants with clinically significant physical examination abnormalities
Prazo: Up to week 12
|
Up to week 12
|
Change in antibody titers of vaccine immunization for tetanus
Prazo: Up to week 12
|
Up to week 12
|
Change in antibody titers of vaccine immunization for diphtheria
Prazo: Up to week 12
|
Up to week 12
|
Change in antibody titers of vaccine immunization for pneumococcus
Prazo: Up to week 12
|
Up to week 12
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
PK parameter of single-ascending IV doses of BIIB063: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)
Prazo: Up to week 12
|
Up to week 12
|
PK parameter of single-ascending IV doses of BIIB063: Area under the concentration-time curve from time zero to infinity (AUCinf)
Prazo: Up to week 12
|
Up to week 12
|
PK parameter of single-ascending IV doses of BIIB063: Maximum observed concentration (Cmax)
Prazo: Up to week 12
|
Up to week 12
|
PK parameter of single-ascending IV doses of BIIB063: Time to reach maximum observed concentration (Tmax)
Prazo: Up to week 12
|
Up to week 12
|
PK parameter of single-ascending IV doses of BIIB063: Terminal elimination half-life (t1/2)
Prazo: Up to week 12
|
Up to week 12
|
PK parameter of single-ascending IV doses of BIIB063: Clearance (CL)
Prazo: Up to week 12
|
Up to week 12
|
PK parameter of single-ascending IV doses of BIIB063: Volume of distribution at steady state (Vss)
Prazo: Up to week 12
|
Up to week 12
|
PK parameter of a single SC dose of BIIB063: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)
Prazo: Up to week 12
|
Up to week 12
|
PK parameter of a single SC dose of BIIB063: Area under the concentration-time curve from time zero to infinity (AUCinf)
Prazo: Up to week 12
|
Up to week 12
|
PK parameter of a single SC dose of BIIB063: Maximum observed concentration (Cmax)
Prazo: Up to week 12
|
Up to week 12
|
PK parameter of a single SC dose of BIIB063: Time to reach maximum observed concentration (Tmax)
Prazo: Up to week 12
|
Up to week 12
|
PK parameter of a single SC dose of BIIB063: Terminal elimination half-life (t1/2)
Prazo: Up to week 12
|
Up to week 12
|
PK parameter of a single SC dose of BIIB063 Apparent total body clearance (CL/F)
Prazo: Up to week 12
|
Up to week 12
|
PK parameter of a single SC dose of BIIB063: Apparent volume of distribution during terminal elimination phase (Vz/F)
Prazo: Up to week 12
|
Up to week 12
|
PK parameter of a single SC dose of BIIB063: Absolute Bioavailability (F)
Prazo: Up to week 12
|
Up to week 12
|
Number of participants with positive serum anti-BIIB063 antibodies
Prazo: Up to week 12
|
Up to week 12
|
Percentage of participants with positive anti-BIIB063 titers within 12 weeks after administration of BIIB063
Prazo: Up to 12 weeks
|
Up to 12 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
30 de setembro de 2015
Conclusão Primária (Real)
1 de junho de 2016
Conclusão do estudo (Real)
1 de junho de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
27 de agosto de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de setembro de 2015
Primeira postagem (Estimativa)
21 de setembro de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de abril de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de abril de 2017
Última verificação
1 de abril de 2017
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 234HV101
- 2015-001283-18 (Número EudraCT)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .