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NCT06454721 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Biogen.

Completed
Registry status
Phase 1
Development phase
5
Enrollment target

NCT06454721 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 5 participants.

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The verdict

NCT06454721, a Phase 1 study, has completed, sponsored by Biogen.

COMPLETED
Registry status
Phase 1
Development phase
5 participants
Enrollment target

Study 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.

Interventions

  • DRUG [89Zr]Zr-DFO-Diranersen
  • DRUG Diranersen

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2025-01-30
Est. Completion 2026-03-05
Phase Phase 1

Sponsor

Biogen

334 total trials

What the Registry Record Tells You About NCT06454721

The ClinicalTrials.gov registry entry for NCT06454721 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which [89Zr]Zr-DFO-Diranersen is the first listed.

NCT06454721 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT06454721 about?

NCT06454721 is a clinical study titled "A Study to Determine the Biodistribution, Safety, and Tolerability of a Microdose of Radiolabeled Diranersen (BIIB080) Co-administered With Diranersen in Healthy Adults". 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...

What is the current status of trial NCT06454721?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2025-01-30. Estimated completion is 2026-03-05.

What interventions are being tested in trial NCT06454721?

The interventions under investigation include: [89Zr]Zr-DFO-Diranersen (DRUG), Diranersen (DRUG).

Who is sponsoring clinical trial NCT06454721?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.