Trials / Completed
CompletedNCT02833142
Pharmacokinetics, Safety and Tolerability of Single Doses of BIIB033 (Opicinumab) Produced by 2 Manufacturing Processes
A Randomized, Blinded, Parallel-Group, Phase 1 Study of Pharmacokinetics, Safety and Tolerability of Single Intravenous Doses of BIIB033 (Opicinumab ) Produced by 2 Manufacturing Processes, in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of the study is to characterize the pharmacokinetics (PK) of BIIB033-B and to compare the PK profile with that of BIIB033-A in healthy volunteers. Secondary objectives are: To assess the safety and tolerability of BIIB033-A and BIIB033-B; To assess the secondary PK parameters of BIIB033-A and BIIB033-B; To assess the immunogenicity of BIIB033-A and BIIB033-B.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BIIB033 (opicinumab) |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2016-11-01
- Completion
- 2016-11-01
- First posted
- 2016-07-14
- Last updated
- 2016-12-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02833142. Inclusion in this directory is not an endorsement.