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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

2026年7月24日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

48

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • Nevada
      • Las Vegas、Nevada、美国、89113
        • 招聘中
        • Las Vegas Clinical Research Unit, PPD Development, LP
        • 接触：
          • 电话号码：702-963-1600
        • 首席研究员：
          • Aishwarya Vyas Lahar

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：顺序分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：BIIB144 Cohort 1
Participants will receive Dose A of BIIB144 or a matching placebo via intravenous (IV) infusion on Day 1.
药品：安慰剂
管理IV
药品：BIIB144
Administered IV
实验性的：BIIB144 Cohort 2
Participants will receive Dose B of BIIB144 or a matching placebo via IV infusion on Day 1.
药品：安慰剂
管理IV
药品：BIIB144
Administered IV
实验性的：BIIB144 Cohort 3
Participants will receive Dose C of BIIB144 or a matching placebo via IV infusion on Day 1.
药品：安慰剂
管理IV
药品：BIIB144
Administered IV
实验性的：BIIB144 Cohort 4
Participants will receive Dose D of BIIB144 or a matching placebo via IV infusion on Day 1.
药品：安慰剂
管理IV
药品：BIIB144
Administered IV
实验性的：BIIB144 Cohort 5
Participants will receive Dose E of BIIB144 or a matching placebo via IV infusion on Day 1.
药品：安慰剂
管理IV
药品：BIIB144
Administered IV
实验性的：BIIB144 Cohort 6
Participants will receive Dose F of BIIB144 or a matching placebo via IV infusion on Day 1.
药品：安慰剂
管理IV
药品：BIIB144
Administered IV

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
大体时间：Up to Day 280
Up to Day 280

次要结果测量

结果测量
大体时间
Area Under the Serum Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC0-last) of BIIB144
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Biogen

调查人员

  • 研究主任：Medical Director、Biogen

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月21日

初级完成 (估计的)

2028年6月19日

研究完成 (估计的)

2028年6月19日

研究注册日期

首次提交

2026年6月18日

首先提交符合 QC 标准的

2026年6月18日

首次发布 (实际的)

2026年6月23日

研究记录更新

最后更新发布 (实际的)

2026年7月27日

上次提交的符合 QC 标准的更新

2026年7月24日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 301HV101

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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