ACTIVE_NOT_RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-30

Study Completion:2026-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06454721

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Medical Director

STUDY_DIRECTOR

Biogen

Study Locations (Sites)

UC Davis

Sacramento, California, 95817

United States

Collaborators and Investigators

Sponsor: Biogen

Medical Director, STUDY_DIRECTOR, Biogen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-30

Study Completion Date2026-07-30

Study Record Updates

Study Start Date2025-01-30

Study Completion Date2026-07-30

Terms related to this study

Additional Relevant MeSH Terms

Healthy Volunteer