A Study to Determine the Biodistribution, Safety, and Tolerability of a Microdose of Radiolabeled Diranersen (BIIB080) Co-administered With Diranersen in Healthy Adults
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
5actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-01-30 | actual | When the study began enrolling |
| Primary completion | 2026-03-05 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-03-05 | actual | The whole study's end, after follow-up |
| First posted | 2024-06-12 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Volunteer
Interventions
- Drug: [89Zr]Zr-DFO-Diranersen
- Drug: Diranersen — also filed as ISIS 814907, BIIB080
Primary outcome
what the primary-completion date above is the date OFCNS Biodistribution of [89Zr]Zr-DFO-Diranersen Assessed as the Percentage of Dose Taken up by Each Region of Interest (ROI)
measured Post-dose on Days 1, 2, 5, and 8
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