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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

RecruitingPhase 1Ages 18 Years - 55 YearsAllBiogen
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • BIIB144
  • Placebo
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Where

1 site
Las Vegas Clinical Research Unit, PPD Development, LP
Las Vegas, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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