Research Site
Madison, Wisconsin, 53704, United States
NCT Number: NCT02833142
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Madison, Wisconsin, 53704, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Time frame: Up to Day 89
Time frame: Day 85
Time frame: Up to Day 89
Time frame: Up to 17 weeks
Time frame: Up to 17 weeks
Time frame: Up to 17 weeks
Time frame: Up to 17 weeks
Time frame: Up to 17 weeks
Time frame: Up to Day 89
Time frame: Up to Day 89
Time frame: Up to Day 89
Time frame: Up to Day 89
Time frame: Pre-dose, Day 22 and Day 85
Biogen
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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