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COMPLETED
NCT06454721
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

DRUG

[89Zr]Zr-DFO-Diranersen

Administered as specified in the treatment arm.

DRUG

Diranersen

Administered as specified in the treatment arm.

Locations (1)

UC Davis

Sacramento, California, United States