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A Study to Learn More About the Safety of BIIB145 and How it is Processed in the Body of Healthy Adult Participants

Biogen · 2025
ClinicalTrials.gov · Datasets · License: Public Domain · 2025
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healthy-volunteer
In this study, researchers will learn for the first time about the safety of a study drug called BIIB145 and how the body responds to it. This is a "Phase 1" study. This kind of study is an early step in clinical research where the goal is to focus on the safety of the study drug. Another goal may be to learn how the study drug is processed by the body. BIIB145 was designed to help people with multiple sclerosis (MS). But, before it can be tested in people with MS, it must first be tested in healthy volunteers to learn about its safety and other effects. The main goal of this study is to learn about the safety of BIIB145 and how it is processed by the body, with or without food. The main questions researchers want to answer are: * How many participants have adverse events and serious adverse events during the study? An adverse event is a health problem that may or may not be caused by the study drug. * How does BIIB145 affect the participants' overall health? Researchers will also learn more about: * How BIIB145 is processed by the body, with or without food. 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 participants will check into the study research center. * There will be 3 parts to this study. * Part 1: Participants will take a single dose of BIIB145 or a placebo after not eating overnight. 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. Participants in Part 1 will be in the study for up to 42 days. * Part 2: This part of the study will have a "crossover" design. This means that all participants in Part 2 will all take BIIB145 twice, once with food and once without food. When taken with food, they will finish a meal about 30 minutes before their dose. Without food, they will not eat overnight before taking their dose. But, the order in which th
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