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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: Completed Phase 1 study, sponsored by Biogen.
NCT06454721 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
CNS biodistribution of \[89Zr\]Zr-DFO-Diranersen will be measured using the Positron Emission tomography (PET) imaging. The mean radioactive counts per voxel will be measured. These counts will be converted to the percentage of dose that is taken up by each ROI (% of injected tracer dose per gram of tissue) to quantify the biodistribution in measurable tissues and CSF spaces at relative distances from the lumbar injection using quantitative scaling algorithms.
Interventions
- DRUG [89Zr]Zr-DFO-Diranersen
- DRUG Diranersen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2025-01-30 |
| Est. Completion | 2026-03-05 |
| Phase | Phase 1 |
What the finished NCT06454721 record still lists
NCT06454721 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which [89Zr]Zr-DFO-Diranersen is the first listed.
NCT06454721 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06454721's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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