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[89Zr]Zr-DFO-Diranersen

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

Ensayo de BIOGEN INC. en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

5

previstos

Centros

1

Fin del objetivo primario

mar 2026

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en ene 2025.

Qué mide

CNS Biodistribution of [89Zr]Zr-DFO-Diranersen Assessed as the Percentage of Dose Taken up by Each Region of Interest (ROI) (Post-dose on Days 1, 2, 5, and 8) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroIn 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.

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Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06454721), actualizada en jul 2026.