Trials / Completed
CompletedNCT01052506
BIIB033 Single Ascending Dose Study in Healthy Volunteer Subjects
A Randomized, Blinded, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Healthy Adult Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 25 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of the study is to evaluate the safety and tolerability of single dose of BIIB033 administered to healthy adult volunteers.
Detailed description
BIIB033 is an investigational product being developed to promote remyelination in subjects with multiple sclerosis (MS). This healthy volunteer study will evaluate safety and tolerability of a single dose of BIIB033.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BIIB033 | Single, escalating doses of BIIB033 (8 cohorts IV, 1 cohort SC) |
| DRUG | Placebo | Single dose of placebo comparator (8 cohorts IV, 1 cohort SC) |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2011-10-01
- Completion
- 2011-10-01
- First posted
- 2010-01-20
- Last updated
- 2017-01-09
Locations
2 sites across 2 countries: United States, Netherlands
Source: ClinicalTrials.gov record NCT01052506. Inclusion in this directory is not an endorsement.