A Study to Determine the Biodistribution, Safety, and Tolerability of a Microdose of Radiolabeled Diranersen (BIIB080) Co-administered With Diranersen in Healthy Adults
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.
Timeline
- Start
- 2025-01-30
- Primary completion
- 2026-03-05
- Completion
- 2026-03-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diranersen | Antisense oligonucleotide | — | Intrathecal |
| Subject | [89Zr]Zr-DFO-Diranersen | Diagnostic / imaging agent | — | Intrathecal |
Indications
No indication recorded.