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Also known as [89Zr]Zr-DFO-Diranersen
Zr-DFO-Diranersen · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| [89Zr]Zr-DFO-Diranersen+ Diranersen | EXPERIMENTAL | Participants 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. |
| Name | Type | Description |
|---|---|---|
| [89Zr]Zr-DFO-Diranersen | DRUG | Administered as specified in the treatment arm. |
| Diranersen | DRUG | Administered as specified in the treatment arm. |
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...
Zr-DFO-Diranersen is a radiolabeled imaging agent built from diranersen, an antisense oligonucleotide developed by Biogen. It combines diranersen with a zirconium-89 radiolabel and was studied in a Phase 1 trial to determine biodistribution, safety, and tolerability when given as a microdose alongside diranersen in healthy adult volunteers.
Zr-DFO-Diranersen was studied as a research imaging agent to show where diranersen distributes in the body. Its single Phase 1 trial enrolled healthy adult volunteers in the United States and assessed biodistribution, safety, and tolerability of a microdose co-administered with diranersen. No patient indication has been disclosed for this radiolabeled agent.
Zr-DFO-Diranersen carries diranersen, an antisense oligonucleotide whose target class is described as -sen (ASO). The zirconium-89 label allows imaging of the distribution of the antisense oligonucleotide rather than a therapeutic effect. The specific molecular target of diranersen is not disclosed in the available program information.
Zr-DFO-Diranersen is being developed by Biogen Inc., which trades on Nasdaq under the ticker BIIB. Biogen is the sponsor of the single Phase 1 study of the radiolabeled agent, which was conducted in the United States in healthy adult volunteers.
Zr-DFO-Diranersen has been studied in a Phase 1 clinical trial, which is now completed. It is an investigational agent and is not approved by the FDA. The trial was an uncontrolled, non-randomized study with five enrolled participants.
Zr-DFO-Diranersen was evaluated in one clinical trial, NCT06454721, titled a study to determine the biodistribution, safety, and tolerability of a microdose of radiolabeled diranersen (BIIB080) co-administered with diranersen in healthy adults. The Phase 1 trial enrolled five healthy volunteers in the United States and is completed.
Yes. Zr-DFO-Diranersen is also known as [89Zr]Zr-DFO-Diranersen. The bracketed form names the zirconium-89 radionuclide used in the chelator DFO, so both names refer to the same radiolabeled antisense oligonucleotide imaging agent developed by Biogen.