NCT05575011 - A Study to Learn About the Safety of BIIB115 Injections and How BIIB115 is Processed in the Bodies of Healthy Adult Male Volunteers and of Pediatric Participants With Spinal Muscular Atrophy Who Previously Took Onasemnogene Abeparvovec | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 10, 2022

Primary Completion Date

November 14, 2031

Study Completion Date

November 14, 2031

Conditions

Healthy VolunteerMuscular Atrophy, Spinal

Interventions

DRUG

BIIB115

Administered as specified in the treatment arm

DRUG

BIIB115-Matching Placebo

Administered as specified in the treatment arm

Trial Locations (17)

2333

Centre For Human Drug Research, Leiden

9000

Universitair Ziekenhuis Gent, Ghent

20162

Fondazione Serena Onlus - Centro Clinico Nemo, Milan

45147

Universitatsklinikum Essen, Essen

69120

Universitaetsklinikum Heidelberg, Heidelberg

75012

Hôpital Armand Trousseau, Paris

79106

Universitaetsklinikum Freiburg, Freiburg im Breisgau

K1H 8L1

Children's Hospital of Eastern Ontario, Ontario

00168

Pediatric Neurology Unit, Catholic University, Rome

3584 CX

UMC Utrecht, Utrecht

93-338

Instytut Centrum Zdrowia Matki Polki Dept of Neurology, Lodz

02-172

PRATIA S.A. MTZ Clinical Research Powered by Pratia, Warsaw

04-730

"Instytut Pomnik - Centrum Zdrowia Dziecka", Warsaw

700-721

Kyungpook National University Hospital, Daegu

03080

Seoul National University Hospital, Seoul

WC1N 3JH

Great Ormond Street Hospital for Children, Bloomsbury

S10 2TH

Sheffield Childrens Hospital, Sheffield