Pharmacokinetics, Safety and Tolerability of Single Doses of BIIB033 (Opicinumab) Produced by 2 Manufacturing Processes
Completed · Phase 1
Conditions studied: Multiple Sclerosis, Acute Optic Neuritis
In brief
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.
Key facts
- Study ID
- NCT02833142
- Run by
- Biogen
- People needed
- 28
- Starts
- 2016-07-01
- Expected to finish
- 2016-11-01
- Last updated by the study team
- 2016-12-08
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
Where it is running
- Research Site — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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