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
Overview
- Phase
- Phase 1
- Intervention
- BIIB076
- Conditions
- Alzheimer's Disease
- Sponsor
- Biogen
- Enrollment
- 46
- Locations
- 8
- Primary Endpoint
- Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort HV1
Intervention: BIIB076
Cohort HV1
Intervention: Placebo
Cohort HV2
Intervention: BIIB076
Cohort HV2
Intervention: Placebo
Cohort HV3
Intervention: BIIB076
Cohort HV3
Intervention: Placebo
Cohort HV4
Intervention: BIIB076
Cohort HV4
Intervention: Placebo
Cohort HV5
Intervention: BIIB076
Cohort HV5
Intervention: Placebo
Cohort AD1
Intervention: BIIB076
Cohort AD1
Intervention: Placebo
Outcomes
Primary Outcomes
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to Week 20
Safety surveillance
Secondary Outcomes
- BIIB076 serum pharmacokinetics (PK) concentration levels(Up to Week 20)
- PK parameter of BIIB076: Area under the concentration-time curve from time zero to infinity (AUCinf)(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)(Up to Week 20)
- PK parameter of BIIB076: Maximum observed concentration (Cmax)(Up to Week 20)
- PK parameter of BIIB076: Time to reach maximum observed concentration (Tmax)(Up to Week 20)
- PK parameter of BIIB076: Terminal elimination half-life (t1/2)(Up to Week 20)
- PK parameter of BIIB076: Clearance (CL)(Up to Week 20)
- PK parameter of BIIB076: Volume of distribution (Vd)(Up to Week 20)
- Number of participants with positive serum BIIB076 antibodies(Up to Week 20)