Recent Updates
Recently added Catalysts

Zr-DFO-Diranersen

Phase 1

Healthy Volunteer | Small molecule | Other |Biogen Inc.|Last Updated: Jul 10, 2026

Target and mechanism

ModalitySmall molecule

Also known as [89Zr]Zr-DFO-Diranersen

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment5

FDA Designations

FAST_TRACK

Clinical trial landscape

Zr-DFO-Diranersen · 1 trial · 1 indication

Phase 1 1
NCT06454721A Study to Determine the Biodistribution, Safety, and Tolerability of a Microdose of Radiolabeled Diranersen (BIIB080) Co-administered With Diranersen in Healthy AdultsHealthy Volunteer
COMPLETED5 Analytics
PHASE1COMPLETED
A Study to Determine the Biodistribution, Safety, and Tolerability of a Microdose of Radiolabeled Diranersen (BIIB080) Co-administered With Diranersen in Healthy Adults
Healthy Volunteer
NCT064547215
Unlock trial analytics

Study Endpoints

Primary Endpoints

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

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.

Secondary Endpoints

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Up to 197 days
Dosimetry: Dose of Radiation Absorbed as Measured by PET Imaging Test
Post-dose on Days 1, 2, 5, and 8
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
[89Zr]Zr-DFO-Diranersen+ DiranersenEXPERIMENTALParticipants will receive a single injection of a small dose of radiolabeled diranersen \[89Zr\]Zr-DFO-diranersen) along with a dose of diranersen together via an intrathecal (IT) injection.

Interventions

NameTypeDescription
[89Zr]Zr-DFO-DiranersenDRUGAdministered as specified in the treatment arm.
DiranersenDRUGAdministered as specified in the treatment arm.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Must be healthy adult and have a body mass index (BMI) 18 through 30 kilograms per square meter (kg/m\^2). * Males must practice highly effective contraception and females must be of no childbearing potential. Key Exclusion Criteria: * Conditions that influence cerebrosp...

Countries:United States
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

MEDIUMAug 10, 2026NCT06454721TRIAL_REMOVED: changed
MEDIUMAug 10, 2026NCT06454721TRIAL_REMOVED: changed