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Trial record 1 of 1 for:    BIIB076 biogen
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Single-Ascending-Dose Study of BIIB076 in Healthy Volunteers and Participants With Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT03056729
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date  ICMJE February 15, 2017
First Posted Date  ICMJE February 17, 2017
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE February 17, 2017
Actual Primary Completion Date March 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 20 ]
Safety surveillance
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
  • Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 20 ]
  • Number of participants with clinically significant laboratory assessment abnormalities [ Time Frame: Up to Week 20 ]
  • Number of participants with clinically significant vital sign abnormalities [ Time Frame: Up to Week 20 ]
  • Number of participants with clinically significant physical examination abnormalities [ Time Frame: Up to Week 20 ]
  • Number of participants with clinically significant neurological examination abnormalities [ Time Frame: Up to Week 20 ]
  • Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities [ Time Frame: Up to Week 20 ]
  • Number of participants with clinically significant brain magnetic resonance imaging (MRI) abnormalities [ Time Frame: Up to Week 20 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
  • BIIB076 serum pharmacokinetics (PK) concentration levels [ Time Frame: Up to Week 20 ]
    Assessment of BIIB076 pharmacokinetics in blood
  • 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
  • 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
  • PK parameter of BIIB076: Maximum observed concentration (Cmax) [ Time Frame: Up to Week 20 ]
    Assessment of BIIB076 pharmacokinetics in blood
  • PK parameter of BIIB076: Time to reach maximum observed concentration (Tmax) [ Time Frame: Up to Week 20 ]
    Assessment of BIIB076 pharmacokinetics in blood
  • PK parameter of BIIB076: Terminal elimination half-life (t1/2) [ Time Frame: Up to Week 20 ]
    Assessment of BIIB076 pharmacokinetics in blood
  • PK parameter of BIIB076: Clearance (CL) [ Time Frame: Up to Week 20 ]
    Assessment of BIIB076 pharmacokinetics in blood
  • PK parameter of BIIB076: Volume of distribution (Vd) [ Time Frame: Up to Week 20 ]
    Assessment of BIIB076 pharmacokinetics in blood
  • Number of participants with positive serum BIIB076 antibodies [ Time Frame: Up to Week 20 ]
    Serological assessment (of anti-BIIB076 antibodies in blood)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
  • BIIB076 serum pharmacokinetics (PK) concentration levels [ Time Frame: Up to Week 20 ]
  • PK parameter of BIIB076: Area under the concentration-time curve from time zero to infinity (AUCinf) [ Time Frame: Up to Week 20 ]
  • 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 ]
  • PK parameter of BIIB076: Maximum observed concentration (Cmax) [ Time Frame: Up to Week 20 ]
  • PK parameter of BIIB076: Time to reach maximum observed concentration (Tmax) [ Time Frame: Up to Week 20 ]
  • PK parameter of BIIB076: Terminal elimination half-life (t1/2) [ Time Frame: Up to Week 20 ]
  • PK parameter of BIIB076: Clearance (CL) [ Time Frame: Up to Week 20 ]
  • PK parameter of BIIB076: Volume of distribution (Vd) [ Time Frame: Up to Week 20 ]
  • Number of participants with positive serum BIIB076 antibodies [ Time Frame: Up to Week 20 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single-Ascending-Dose Study of BIIB076 in Healthy Volunteers and Participants With Alzheimer's Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Alzheimer's Disease
  • Healthy Volunteer
Intervention  ICMJE
  • Drug: BIIB076
    Administered as single intravenous (IV) infusion
  • Drug: Placebo
    Administered as single IV infusion
Study Arms  ICMJE
  • Experimental: Cohort HV1
    Interventions:
    • Drug: BIIB076
    • Drug: Placebo
  • Experimental: Cohort HV2
    Interventions:
    • Drug: BIIB076
    • Drug: Placebo
  • Experimental: Cohort HV3
    Interventions:
    • Drug: BIIB076
    • Drug: Placebo
  • Experimental: Cohort HV4
    Interventions:
    • Drug: BIIB076
    • Drug: Placebo
  • Experimental: Cohort HV5
    Interventions:
    • Drug: BIIB076
    • Drug: Placebo
  • Experimental: Cohort AD1
    Interventions:
    • Drug: BIIB076
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2019)
46
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2017)
56
Actual Study Completion Date  ICMJE March 3, 2020
Actual Primary Completion Date March 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03056729
Other Study ID Numbers  ICMJE 243HV101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP