Trials / Completed
CompletedNCT03056729
Single-Ascending-Dose Study of BIIB076 in Healthy Volunteers and Participants With Alzheimer's Disease
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 50 Years – 80 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BIIB076 | Administered as single intravenous (IV) infusion |
| DRUG | Placebo | Administered as single IV infusion |
Timeline
- Start date
- 2017-02-17
- Primary completion
- 2020-03-03
- Completion
- 2020-03-03
- First posted
- 2017-02-17
- Last updated
- 2020-03-24
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03056729. Inclusion in this directory is not an endorsement.