BIIB080 Study in Healthy Adults

Overseen By Global Biogen Clinical Trial Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Biogen

Must not be taking: Prescription medications, Over-the-counter medications

Disqualifiers: Cardiac, Neurologic, Psychiatric, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

5 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Medical Director

Principal Investigator

Biogen

Eligibility Criteria

This trial is for healthy adults with a BMI of 18-30 kg/m^2. Men must use effective contraception, and women cannot be able to bear children. It's designed to understand how a potential Alzheimer's drug behaves in the body.

Inclusion Criteria

I am a healthy adult with a BMI between 18 and 30.

I am using a highly effective method of birth control.

I cannot become pregnant.

Exclusion Criteria

My MRI does not show any conditions that could risk my safety in the study.

I have a health condition affecting my heart, hormones, blood, liver, immune system, metabolism, urinary system, lungs, nerves, skin, mental health, kidneys, or I have cancer.

Severe allergic or anaphylactic reactions/systemic hypersensitivity to BIIB080 or any component of the study treatment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of a small dose of radiolabeled BIIB080 and a dose of BIIB080 via an intrathecal injection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and biodistribution of the radiolabeled drug using PET imaging

8 days

4 visits (in-person) on Days 1, 2, 5, and 8

Long-term safety monitoring

Participants are monitored for adverse events and serious adverse events

Up to 197 days

Treatment Details

Interventions

• BIIB080

Trial Overview Researchers are testing BIIB080, an experimental Alzheimer's drug, by tracking its distribution in the brain and spinal cord using PET scans after injecting it alongside a radiolabeled version called [89Zr]Zr-DFO-BIIB080.

Participant Groups

Group I: [89Zr]Zr-DFO-BIIB080 + BIIB080 Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Biogen

Lead Sponsor

Trials

655

Recruited

468,000+

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada