Investigating the distribution and safety of a new drug for Alzheimer's in healthy adults
A Phase 1, Open-Label Study to Determine the Biodistribution, Safety, and Tolerability of a Microdose of Radiolabeled BIIB080 Co-administered With BIIB080 in Healthy Adults
This study is testing how a new Alzheimer's drug called BIIB080 spreads in the brain and spinal cord of healthy adults to ensure it's safe before using it in patients with Alzheimer's.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Biogen Industry-sponsored |
| Drugs / interventions | Radiation |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT06454721 on ClinicalTrials.gov |
What this trial studies
This study aims to understand how a drug called BIIB080, which is being developed for Alzheimer's disease, distributes in the brain and spinal cord. Researchers will administer a microdose of radiolabeled BIIB080 alongside a standard dose of BIIB080 through an intrathecal injection in healthy volunteers. The distribution will be monitored using a positron emission tomography (PET) scanner to assess safety and tolerability. The study focuses on healthy adults to gather baseline data before testing in patients with Alzheimer's.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 65 with a BMI between 18 and 30.
Not a fit: Patients with conditions affecting cerebrospinal fluid kinetics or those who have contraindications for MRI or PET scans may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide crucial insights into the drug's behavior in the brain, potentially leading to improved treatments for Alzheimer's disease.
How similar studies have performed: While this approach is novel in the context of BIIB080, similar studies using radiolabeled compounds for drug distribution have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Where this trial is running
Sacramento, California
- UC Davis — Sacramento, California, United States (Recruiting)
Study contacts
- Study coordinator: US Biogen Clinical Trial Center
- Email: clinicaltrials@biogen.com
- Phone: 866-633-4636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.