A Study to Learn More About the Safety of a Single Dose of BIIB144 and How it is Processed in the Body of Healthy Adult Participants Ages 18 to 55 Years Old as Compared to a Placebo
24 de julho de 2026 atualizado por: Biogen
A Phase 1, Randomized, Blinded, Placebo-Controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB144 in Healthy Adult Participants
In this study, researchers will learn how the body processes a study drug called BIIB144. This is a "first-in-human" study. This means that this study drug will be given to people for the first very time in this study. These studies are important because they help researchers learn about the safety of the study drug, how the body processes it, and what dose might be appropriate before testing it in larger groups.
The main goal of this study is to learn more about the safety of a single dose of BIIB144 compared to a placebo. A placebo is something that looks like the study drug but does not contain any medicine. A placebo is also given in the same way as the study drug.
The main question researchers want to answer in this study is:
How many participants have adverse events (AEs) and serious adverse events (SAEs)? An AE is a health problem that may or may not be caused by the study drug.
Researchers will also learn more about:
- How the body processes BIIB144 compared to placebo.
This study will be done as follows:
- Participants will be screened to check if they can join the study. The screening period will be up to 28 days, after which eligible participants will check into their study research center.
- Participants will stay at their study research center for about 8 days. Afterwards, they will have up to 13 visits to their study research center.
- This will be a "dose escalation" study. In this kind of study, increasing amounts of study drug are given to different groups of participants. Usually, this is done until researchers find the highest dose that does not cause harmful effects. In this study, the number of dose groups and maximum dose are planned in advance. The dose escalation will stop once these planned groups are done or if safety concerns arise.
- There will be a total of 6 groups. In each group, participants will receive a single dose of either BIIB144 or the placebo through an intravenous (IV) needle.
- Throughout the study, participants will give blood and urine samples. Participants will also have physical exams and answer questions about how they are feeling.
- Each participant will be in the study for up to 44 weeks.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
The primary objective of this study is to evaluate the safety and tolerability of IV administered ascending single doses of BIIB144 compared with placebo in healthy adult participants.
The secondary objective is to characterize the pharmacokinetics (PK) of IV administered ascending single doses of BIIB144 in healthy adult participants.
Tipo de estudo
Intervencional
Inscrição (Estimado)
48
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.
Contato de estudo
- Nome: US Biogen Clinical Trial Center
- Número de telefone: 866-633-4636
- E-mail: clinicaltrials@biogen.com
Estude backup de contato
- Nome: Global Biogen Clinical Trial Center
- E-mail: clinicaltrials@biogen.com
Locais de estudo
-
-
Nevada
-
Las Vegas, Nevada, Estados Unidos, 89113
- Recrutamento
- Las Vegas Clinical Research Unit, PPD Development, LP
-
Contato:
- Número de telefone: 702-963-1600
-
Investigador principal:
- Aishwarya Vyas Lahar
-
-
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
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
Key Inclusion Criteria:
- Have a body mass index (BMI) between 18 and 32 kilograms per square metre (kg/m^2), inclusive, at Screening.
- Must be in good health as determined by the Investigator, based on medical history and Screening evaluations.
Key Exclusion Criteria:
- History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- History of severe allergic or anaphylactic reactions, or of any allergic reactions that in the opinion of the Investigator are likely to be exacerbated by any component of the study treatment.
- History of, or ongoing, malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 1 year prior to Day -1).
- History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
- Any live or attenuated immunization or vaccination given within 14 days prior to Screening, between Screening and Day -1, or planned to be given during the study period.
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 sequencial
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: BIIB144 Cohort 1
Participants will receive Dose A of BIIB144 or a matching placebo via intravenous (IV) infusion on Day 1.
|
Administrado IV
Administered IV
|
|
Experimental: BIIB144 Cohort 2
Participants will receive Dose B of BIIB144 or a matching placebo via IV infusion on Day 1.
|
Administrado IV
Administered IV
|
|
Experimental: BIIB144 Cohort 3
Participants will receive Dose C of BIIB144 or a matching placebo via IV infusion on Day 1.
|
Administrado IV
Administered IV
|
|
Experimental: BIIB144 Cohort 4
Participants will receive Dose D of BIIB144 or a matching placebo via IV infusion on Day 1.
|
Administrado IV
Administered IV
|
|
Experimental: BIIB144 Cohort 5
Participants will receive Dose E of BIIB144 or a matching placebo via IV infusion on Day 1.
|
Administrado IV
Administered IV
|
|
Experimental: BIIB144 Cohort 6
Participants will receive Dose F of BIIB144 or a matching placebo via IV infusion on Day 1.
|
Administrado IV
Administered IV
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Prazo: Up to Day 280
|
Up to Day 280
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC0-last) of BIIB144
Prazo: Pre-dose and at multiple time points post-dose up to Day 280
|
Pre-dose and at multiple time points post-dose up to Day 280
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of BIIB144
Prazo: Pre-dose and at multiple time points post-dose up to Day 280
|
Pre-dose and at multiple time points post-dose up to Day 280
|
|
Maximum Observed Serum Concentration (Cmax) of BIIB144
Prazo: Pre-dose and at multiple time points post-dose up to Day 280
|
Pre-dose and at multiple time points post-dose up to Day 280
|
|
Time to Maximum Observed Serum Concentration (Tmax) of BIIB144
Prazo: Pre-dose and at multiple time points post-dose up to Day 280
|
Pre-dose and at multiple time points post-dose up to Day 280
|
|
Terminal Elimination Half-Life (t½) of BIIB144
Prazo: Pre-dose and at multiple time points post-dose up to Day 280
|
Pre-dose and at multiple time points post-dose up to Day 280
|
|
Total Body Clearance (CL) of BIIB144
Prazo: Pre-dose and at multiple time points post-dose up to Day 280
|
Pre-dose and at multiple time points post-dose up to Day 280
|
|
Volume of Distribution During the Terminal Elimination Phase (Vz) of BIIB144
Prazo: Pre-dose and at multiple time points post-dose up to Day 280
|
Pre-dose and at multiple time points post-dose up to Day 280
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Medical Director, Biogen
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)
21 de julho de 2026
Conclusão Primária (Estimado)
19 de junho de 2028
Conclusão do estudo (Estimado)
19 de junho de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
18 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de junho de 2026
Primeira postagem (Real)
23 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 301HV101
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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