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

NCT06454721 | Completed Phase 1 FDA Drug

• 1 other identifier: 247HV101
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, researchers will learn more about a study drug called BIIB080. BIIB080 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 BIIB080 distributes in the brain and spinal cord. To help answer this question, researchers will use positron emission tomography (PET) scanner that can detect radiolabeled BIIB080 after a single injection of a small dose of radiolabeled BIIB080 (\[89Zr\]Zr-DFO-BIIB080) and a dose of BIIB080 together via an intrathecal (IT) injection in healthy volunteers. Researchers will also learn about the safety of injecting radiolabeled BIIB080 and BIIB080 together.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• CNS Biodistribution of [89Zr]Zr-DFO-BIIB080 Assessed as the Percentage of Dose Taken up by Each Region of Interest (ROI)

  CNS biodistribution of \[89Zr\]Zr-DFO-BIIB080 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.

  Post-dose on Days 1, 2, 5, and 8

Secondary Outcomes (2)

• 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

Study Arms (1)

[89Zr]Zr-DFO-BIIB080 + BIIB080

EXPERIMENTAL

Participants will receive a single injection of a small dose of radiolabeled BIIB080 (\[89Zr\]Zr-DFO-BIIB080) along with a dose of BIIB080 together via an intrathecal (IT) injection.

Drug: [89Zr]Zr-DFO-BIIB080; Drug: BIIB080

Interventions

[89Zr]Zr-DFO-BIIB080 DRUG

Administered as specified in the treatment arm.

[89Zr]Zr-DFO-BIIB080 + BIIB080

BIIB080 DRUG

Administered as specified in the treatment arm.

Also known as: ISIS 814907

[89Zr]Zr-DFO-BIIB080 + BIIB080

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Conditions that influence cerebrospinal fluid (CSF) kinetics e.g., significant scoliosis or a physical disability that limits mobility.
• Contraindication to:
• Magnetic resonance imaging (MRI) scan: e.g., indwelling ferrous metal, implanted medical devices, or claustrophobia.
• Radiation/PET scan: e.g., inability to lie flat or still for the duration of the scan) or intolerance to previous nuclear medicine scans.
• Lumbar Puncture (LP, spinal tap): e.g., current use of a medication that prolongs coagulation times, including aspirin, known disorders of the coagulation cascade, platelet function, or platelet count, low white blood cell counts, chronic low back pain; prior lumbar spine surgery, anatomical factors at or near the spinal tap site, clinical signs of raised intracranial pressure (e.g., headache, or focal neurologic signs).
• Findings from the screening MRI that may interfere with participant safety or the scientific integrity of the study e.g., Chiari malformation, high grade spinal stenosis, hydrocephalus, or neural tube defect.
• Abnormal Laboratory Values e.g., liver functions, anemia, abnormal blood coagulation profile.
• Cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or malignant disease.
• Severe allergic or anaphylactic reactions/ systemic hypersensitivity to BIIB080 or any component of the study treatment.
• Alcohol or substance abuse.
• Plans to undergo elective procedures or surgeries during the study.
• Enrollment in any other drug, biologic, device, or clinical study within 30 days or 5 half-lives, whichever is longer, prior to Check-in.
• Use of any prescription medication (except hormone therapy), over-the-counter medication (excluding acetaminophen), or dietary and herbal supplements (e.g., St. John's wort) within 28 days of the of dosing and during the study.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

UC Davis

Sacramento, California, 95817, United States

Location

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: January 30, 2025
• Primary Completion: March 5, 2026
• Study Completion: March 5, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)