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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort HV1 | Experimental |
| |
| Cohort HV2 | Experimental |
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| Cohort HV3 | Experimental |
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| Cohort HV4 | Experimental |
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| Cohort HV5 | Experimental |
| |
| Cohort AD1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB076 | Drug | Administered as single intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) | Safety surveillance | Baseline up to Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| BIIB076 serum pharmacokinetics (PK) concentration levels | Assessment of BIIB076 pharmacokinetics in blood | Up to Week 20 |
| PK parameter of BIIB076: Area under the concentration-time curve from time zero to infinity (AUCinf) |
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Key Inclusion Criteria - Healthy Participants
Key Inclusion Criteria - Participants with Alzheimer's Disease (AD)
Key Exclusion Criteria - Healthy Participants
Key Exclusion Criteria - Participants with Alzheimer's Disease (AD)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Clinical | Hallandale | Florida | 33009 | United States | ||
| Bioclinica Research |
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| Placebo | Drug | Administered as single IV infusion |
|
Assessment of BIIB076 pharmacokinetics in blood
| 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) | Assessment of BIIB076 pharmacokinetics in blood | Up to Week 20 |
| PK parameter of BIIB076: Maximum observed concentration (Cmax) | Assessment of BIIB076 pharmacokinetics in blood | Up to Week 20 |
| PK parameter of BIIB076: Time to reach maximum observed concentration (Tmax) | Assessment of BIIB076 pharmacokinetics in blood | Up to Week 20 |
| PK parameter of BIIB076: Terminal elimination half-life (t1/2) | Assessment of BIIB076 pharmacokinetics in blood | Up to Week 20 |
| PK parameter of BIIB076: Clearance (CL) | Assessment of BIIB076 pharmacokinetics in blood | Up to Week 20 |
| PK parameter of BIIB076: Volume of distribution (Vd) | Assessment of BIIB076 pharmacokinetics in blood | Up to Week 20 |
| Number of participants with positive serum BIIB076 antibodies | Serological assessment (of anti-BIIB076 antibodies in blood) | Up to Week 20 |
| Orlando |
| Florida |
| 32806 |
| United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | 96817 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| St Louis Clinical Trial | St Louis | Missouri | 63141 | United States |
| Covance Dallas CRU | Dallas | Texas | 75247 | United States |
| Covance CRU | Madison | Wisconsin | 53704 | United States |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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