BIIB080 Study in Healthy Adults
Trial Summary
What is the purpose of this trial?
In this study, researchers will learn more about a study drug called BIIB080. BIIB080 is currently a drug under investigation for treatment of Alzheimer's disease. The main question researchers are trying to answer in this study is how radiolabeled BIIB080 distributes in the brain and spinal cord. To help answer this question, researchers will use positron emission tomography (PET) scanner that can detect radiolabeled BIIB080 after a single injection of a small dose of radiolabeled BIIB080 (\[89Zr\]Zr-DFO-BIIB080) and a dose of BIIB080 together via an intrathecal (IT) injection in healthy volunteers. Researchers will also learn about the safety of injecting radiolabeled BIIB080 and BIIB080 together.
Research Team
Medical Director
Principal Investigator
Biogen
Eligibility Criteria
This trial is for healthy adults with a BMI of 18-30 kg/m^2. Men must use effective contraception, and women cannot be able to bear children. It's designed to understand how a potential Alzheimer's drug behaves in the body.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single injection of a small dose of radiolabeled BIIB080 and a dose of BIIB080 via an intrathecal injection
Follow-up
Participants are monitored for safety and biodistribution of the radiolabeled drug using PET imaging
Long-term safety monitoring
Participants are monitored for adverse events and serious adverse events
Treatment Details
Interventions
- BIIB080
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Who Is Running the Clinical Trial?
Biogen
Lead Sponsor
Daniel Quirk
Biogen
Chief Medical Officer
MD
Christopher A. Viehbacher
Biogen
Chief Executive Officer since 2022
Graduated from Queen's University, Kingston, Ontario, Canada