A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB115
About the study
The primary objective of the study is to evaluate the safety and tolerability of single ascending dose of BIIB115 administered via intrathecal (IT) bolus injection to healthy male participants in Part A and multiple ascending doses of BIIB115 administered via IT bolus injection to pediatric Spinal Muscular Atrophy (SMA) participants previously treated with onasemnogene abeparvovec in Part B. The secondary objective of the study is to evaluate the pharmacokinetics (PK) of single-dose of BIIB115 administered via IT bolus injection to healthy male participants in Part A and multiple ascending doses of BIIB115 administered via IT bolus injection to pediatric SMA participants who previously received onasemnogene abeparvovec in Part B.
Study Locations
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How to Apply
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Study’s details
Contition
Healthy Volunteer,Muscular Atrophy, Spinal
Age (in years)
6 - 55
Phase
Phase 1
Participants needed
62
Est. Completion Date
May 26, 2027
Treatment type
Interventional
Sponsor
Biogen
ClinicalTrials.gov identifier
NCT05575011
Study number
277HV101
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