A Study to Determine the Biodistribution, Safety, and Tolerability of a Microdose of Radiolabeled Diranersen (BIIB080) Co-administered With Diranersen in Healthy Adults

Completed · Phase 1

Conditions studied: Healthy Volunteer

In brief

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.

Key facts

Study ID
NCT06454721
Run by
Biogen
People needed
5
Starts
2025-01-30
Expected to finish
2026-03-05
Last updated by the study team
2026-07-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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