CompletedPhase 1

Single-Ascending-Dose Study of BIIB076 in Healthy Volunteers and Participants With Alzheimer's Disease

A Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB076 in Healthy Volunteers and Subjects With Alzheimer's Disease

Lead sponsor

Biogen

Asset

BIIB076

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•MCI due to AD•Amyloid biomarker required•CDR global 0.5•MMSE 18-30•Healthy volunteers

Primary endpoint

•Number of participants that experience Adverse Events (AEs)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID243HV101

NCT IDNCT03056729

Timeline

Milestones

Study first posted2017-02-17actual

Study start2017-02-17actual

Primary completion2020-03-03actual

Study completion2020-03-03actual

Last update posted2020-03-24actual

Assets

Drug assets

BIIB076

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age80 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

Key Inclusion Criteria - Healthy Participants

•Must be in good health as determined by the Investigator, based on medical history and Screening evaluations.

Key Inclusion Criteria - Participants with Alzheimer's Disease (AD)

•Must meet all of the clinical criteria for mild cognitive impairment (MCI) due to AD or mild AD according to the National Institutes of Aging-Alzheimer's Association [McKhann 2011], and in addition must have the following:

•Clinical Dementia Rating (CDR) global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD.

•CDR Memory Box Score of ≥0.5.

•Mini-Mental State Examination score between 18 and 30 (inclusive) at Screening.

•Must have amyloid beta positivity confirmed at Screening

Exclusion criteria

•Healthy Participants

•Brain MRI findings that might pose a risk to the participant, or might prevent a satisfactory MRI assessment for safety monitoring.

•History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.

•Current enrollment in any other drug, biologic, device, or clinical study or treatment with an investigational drug or approved therapy for investigational use within 30 days (6 months for biologics) or 5 half-lives, whichever is longer, prior to Day-1.

•Contraindications to having a brain MRI (e.g., pacemaker; MRI-incompatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia that cannot be medically managed).

•Contraindications to having an Lumbar Puncture (LP).

Key Exclusion Criteria - Participants with Alzheimer's Disease (AD)

•Any medical or neurologic/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause to the participant's cognitive impairment (e.g.,current history of substance abuse, uncontrolled vitamin B12 deficiency or uncontrolled thyroid disease, stroke or other cerebrovascular condition, Parkinson's disease, Lewy body dementia, or frontotemporal dementia or head trauma), or could lead to discontinuation, noncompliance with study assessments, or safety concerns.

•Diagnosis within 1 year prior to Screening and/or evidence of clinically significant (in the opinion of the Investigator) psychiatric illness including uncontrolled major depression, bipolar affective disorder, other psychiatric illness, and suicidal ideation.

•Any documented prior history of chronic schizophrenia.

•History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary (including chronic obstructive pulmonary disease), neurologic, dermatologic, or renal disease, or other major disease, as determined by the Investigator.

•Use of any medications for the treatment of comorbid conditions that have not been stable for at least 8 weeks prior to Day -1 and/or that are not expected to remain stable for the duration of the study.

•Current enrollment or plan to enroll in any other drug, biologic, device, or clinical study or treatment with an investigational drug or approved therapy for investigational use within 30 days (6 months for biologics) or 5 half-lives, whichever is longer, prior to Day-1.

•Contraindications to having a brain MRI (e.g., pacemaker; MRI-incompatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia that cannot be medically managed).

•Brain MRI findings that might be a contributing cause of the participant's dementia, might pose a risk to the participant, or might prevent a satisfactory MRI assessment for safety monitoring.

•Contraindications to having an LP.

•History of, or ongoing chronic uncontrolled hypertension

•History of unstable angina, myocardial infarction, chronic heart failure (New York Heart Association Class 3 or 4), or clinically significant conduction abnormalities (e.g., unstable atrial fibrillation) within 1 year prior to Day -1.

•Medications with platelet anti-aggregant or anticoagulant properties, except the use of aspirin at a dose ≤325 mg per day.

•For participants whose eligibility for study entry will be based on cerebral Aβ positivityas determined by amyloid PET (positron emission tomography), contraindication to having a PET scan (e.g., inability to lie flat or still for the duration of the scan) or intolerance to previous PET scans (i.e. previous hypersensitivity reactions to any PET radioligand or imaging agent, failure to participate in and comply with previous PET scans).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

9 endpoints

Primary/protocol endpoint

Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:Baseline up to Week 20

event count, event

Secondary/protocol endpoint

BIIB076 serum pharmacokinetics (PK) concentration levels

Time frame:Up to Week 20

concentration, descriptive

Secondary/protocol endpoint

PK parameter of BIIB076: Area under the concentration-time curve from time zero to infinity (AUCinf)

Time frame:Up to Week 20

concentration, descriptive

Secondary/protocol endpoint

PK parameter of BIIB076: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)

Time frame:Up to Week 20

concentration, descriptive

Secondary/protocol endpoint

PK parameter of BIIB076: Maximum observed concentration (Cmax)

Time frame:Up to Week 20

concentration, descriptive

Secondary/protocol endpoint

PK parameter of BIIB076: Time to reach maximum observed concentration (Tmax)

Time frame:Up to Week 20

time to event, event

Secondary/protocol endpoint

PK parameter of BIIB076: Terminal elimination half-life (t1/2)

Time frame:Up to Week 20

concentration, descriptive

Secondary/protocol endpoint

PK parameter of BIIB076: Clearance (CL)

Time frame:Up to Week 20

descriptive

Secondary/protocol endpoint

PK parameter of BIIB076: Volume of distribution (Vd)

Time frame:Up to Week 20

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Number of participants with positive serum BIIB076 antibodies

Time frame:Up to Week 20

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.