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A Study to Determine the Biodistribution, Safety, and Tolerability of a Microdose of Radiolabeled Diranersen (BIIB080) Co-administered With Diranersen in Healthy Adults
Sponsor: Biogen
Summary
In this study, researchers will learn more about a study drug called diranersen (BIIB080). Diranersen 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 diranersen distributes in the brain and spinal cord. To help answer this question, researchers will use positron emission tomography (PET) scanner that can detect radiolabeled diranersen after a single injection of a small dose of radiolabeled diranersen (\[89Zr\]Zr-DFO-diranersen) and a dose of diranersen together via an intrathecal (IT) injection in healthy volunteers. Researchers will also learn about the safety of injecting radiolabeled diranersen and diranersen together.
Official title: A Phase 1, Open-Label Study to Determine the Biodistribution, Safety, and Tolerability of a Microdose of Radiolabeled BIIB080 Co-administered With BIIB080 in Healthy Adults
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
5
Start Date
2025-01-30
Completion Date
2026-03-05
Last Updated
2026-07-10
Healthy Volunteers
Yes
Conditions
Interventions
[89Zr]Zr-DFO-Diranersen
Administered as specified in the treatment arm.
Diranersen
Administered as specified in the treatment arm.
Locations (1)
UC Davis
Sacramento, California, United States