Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    BIIB076 biogen
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03056729
Recruitment Status : Recruiting
First Posted : February 17, 2017
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Healthy Volunteer Drug: BIIB076 Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : February 17, 2017
Estimated Primary Completion Date : February 14, 2020
Estimated Study Completion Date : February 14, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort HV1 Drug: BIIB076
Administered as single intravenous (IV) infusion

Drug: Placebo
Administered as single IV infusion

Experimental: Cohort HV2 Drug: BIIB076
Administered as single intravenous (IV) infusion

Drug: Placebo
Administered as single IV infusion

Experimental: Cohort HV3 Drug: BIIB076
Administered as single intravenous (IV) infusion

Drug: Placebo
Administered as single IV infusion

Experimental: Cohort HV4 Drug: BIIB076
Administered as single intravenous (IV) infusion

Drug: Placebo
Administered as single IV infusion

Experimental: Cohort HV5 Drug: BIIB076
Administered as single intravenous (IV) infusion

Drug: Placebo
Administered as single IV infusion

Experimental: Cohort AD1 Drug: BIIB076
Administered as single intravenous (IV) infusion

Drug: Placebo
Administered as single IV infusion




Primary Outcome Measures :
  1. Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 20 ]
    Safety surveillance


Secondary Outcome Measures :
  1. BIIB076 serum pharmacokinetics (PK) concentration levels [ Time Frame: Up to Week 20 ]
    Assessment of BIIB076 pharmacokinetics in blood

  2. PK parameter of BIIB076: Area under the concentration-time curve from time zero to infinity (AUCinf) [ Time Frame: Up to Week 20 ]
    Assessment of BIIB076 pharmacokinetics in blood

  3. 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 ]
    Assessment of BIIB076 pharmacokinetics in blood

  4. PK parameter of BIIB076: Maximum observed concentration (Cmax) [ Time Frame: Up to Week 20 ]
    Assessment of BIIB076 pharmacokinetics in blood

  5. PK parameter of BIIB076: Time to reach maximum observed concentration (Tmax) [ Time Frame: Up to Week 20 ]
    Assessment of BIIB076 pharmacokinetics in blood

  6. PK parameter of BIIB076: Terminal elimination half-life (t1/2) [ Time Frame: Up to Week 20 ]
    Assessment of BIIB076 pharmacokinetics in blood

  7. PK parameter of BIIB076: Clearance (CL) [ Time Frame: Up to Week 20 ]
    Assessment of BIIB076 pharmacokinetics in blood

  8. PK parameter of BIIB076: Volume of distribution (Vd) [ Time Frame: Up to Week 20 ]
    Assessment of BIIB076 pharmacokinetics in blood

  9. Number of participants with positive serum BIIB076 antibodies [ Time Frame: Up to Week 20 ]
    Serological assessment (of anti-BIIB076 antibodies in blood)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Key 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056729


Contacts
Layout table for location contacts
Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com

Locations
Layout table for location information
United States, Florida
MD Clinical Recruiting
Hallandale Beach, Florida, United States, 33009
Progressive Medical Research Recruiting
Port Orange, Florida, United States, 32127
United States, Indiana
Covance Evansville CRU Withdrawn
Evansville, Indiana, United States, 47710
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
United States, Missouri
St Louis Clinical Trial Recruiting
Saint Louis, Missouri, United States, 63141
United States, Texas
Covance Dallas CRU Active, not recruiting
Dallas, Texas, United States, 75247
United States, Wisconsin
Covance CRU Active, not recruiting
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Biogen
Investigators
Layout table for investigator information
Study Director: Medical Director Biogen

Layout table for additonal information
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03056729     History of Changes
Other Study ID Numbers: 243HV101
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders