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Clinical trial

A Randomized, Blinded, Placebo-Controlled, Phase 1 Single Ascending Dose Study in Healthy Adult Male Volunteers and an Open-Label Multiple Ascending Dose Study With Long-Term Extension in Pediatric SMA Participants Previously Treated With Onasemnogene Abeparvovec (Zolgensma™) to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB115

NCT05575011 is registered in ClinicalTrials.gov with Biogen as lead sponsor.

NCT NCT05575011
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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized, Blinded, Placebo-Controlled, Phase 1 Single Ascending Dose Study in Healthy Adult Male Volunteers and an Open-Label Multiple Ascending Dose Study With Long-Term Extension in Pediatric SMA Participants Previously Treated With Onasemnogene Abeparvovec (Zolgensma™) to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB115
Lead sponsor
Biogen
Phase
Phase 1
Overall status
Active, not recruiting
Start date
October 10, 2022
Completion date
November 14, 2031
Enrollment
62 (actual)
Sites
17

Conditions

As the registry lists them; a condition with its own page is linked.

healthy volunteer, muscular atrophy, spinal