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Alzheimer's DiseasePhase 1NCT03056729

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

A Phase 1 study testing BIIB076 in people with Alzheimer's Disease and Healthy Volunteer, run by Biogen at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the study is to evaluate the safety and tolerability of single-ascending intravenous (IV) infusions of BIIB076 in healthy volunteers and participants with Alzheimer's disease (AD). Read more about this study

Who is it for?
Ages 50 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer's Disease, Healthy Volunteer
What is being tested?
BIIB076
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
8 sitesUnited States
Study dates
17 Feb 2017to 3 Mar 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 20Show fewer
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Covance Dallas CRU

    Dallas, Texas, 75247

  • MD Clinical

    Hallandale, Florida, 33009

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96817

  • Indiana University

    Indianapolis, Indiana, 46202

  • Covance CRU

    Madison, Wisconsin, 53704

  • Bioclinica Research

    Orlando, Florida, 32806

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • St Louis Clinical Trial

    St Louis, Missouri, 63141

Other trials in United States

About this study

Official title: 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

The primary objective of the study is to evaluate the safety and tolerability of single-ascending intravenous (IV) infusions of BIIB076 in healthy volunteers and participants with Alzheimer's disease (AD). A secondary objective of the study for both healthy volunteers and participants with AD is to assess the serum pharmacokinetic(s) (PK) profile of BIIB076 after single-dose administration. Another secondary objective is to evaluate the immunogenicity of BIIB076 in serum after single-dose administration.

Being tested
BIIB076, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIIB076Drug

    Administered as single intravenous (IV) infusion

  • PlaceboDrug

    Administered as single IV infusion

Study groups in NCT03056729
Study groupRoleWhat they receive
Cohort HV1ExperimentalNot described
Receives: Drug: BIIB076; Drug: Placebo
Cohort HV2ExperimentalNot described
Receives: Drug: BIIB076; Drug: Placebo
Cohort HV3ExperimentalNot described
Receives: Drug: BIIB076; Drug: Placebo
Cohort HV4ExperimentalNot described
Receives: Drug: BIIB076; Drug: Placebo
Cohort HV5ExperimentalNot described
Receives: Drug: BIIB076; Drug: Placebo
Cohort AD1ExperimentalNot described
Receives: Drug: BIIB076; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Safety surveillance

    Measured: Baseline up to Week 20

Secondary outcomes (9)

  1. BIIB076 serum pharmacokinetics (PK) concentration levels

    Assessment of BIIB076 pharmacokinetics in blood

    Measured: Up to Week 20

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

    Assessment of BIIB076 pharmacokinetics in blood

    Measured: Up to Week 20

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

    Assessment of BIIB076 pharmacokinetics in blood

    Measured: Up to Week 20

  4. PK parameter of BIIB076: Maximum observed concentration (Cmax)

    Assessment of BIIB076 pharmacokinetics in blood

    Measured: Up to Week 20

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

    Assessment of BIIB076 pharmacokinetics in blood

    Measured: Up to Week 20

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

    Assessment of BIIB076 pharmacokinetics in blood

    Measured: Up to Week 20

  7. PK parameter of BIIB076: Clearance (CL)

    Assessment of BIIB076 pharmacokinetics in blood

    Measured: Up to Week 20

  8. PK parameter of BIIB076: Volume of distribution (Vd)

    Assessment of BIIB076 pharmacokinetics in blood

    Measured: Up to Week 20

  9. Number of participants with positive serum BIIB076 antibodies

    Serological assessment (of anti-BIIB076 antibodies in blood)

    Measured: Up to Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2017
  2. Study start17 Feb 2017
  3. Primary completion3 Mar 2020
  4. Study completion3 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03056729
Sponsor's protocol ID
243HV101
Status last verified
Mar 2020
First submitted
15 Feb 2017
Last updated
24 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIIB076 in people with Alzheimer's Disease and Healthy Volunteer, run by Biogen at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to Week 20). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03056729.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.

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