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BIIB023

Phase 1

Healthy | Monoclonal antibody | Other |Biogen Inc.|Last Updated: Sep 3, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment34
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01943513A Study of the Effect of BIIB023 on Muscle Atrophy in Healthy Male VolunteersPHASE1 COMPLETED 34Oct 1, 2013May 1, 2014Sep 3, 20141 United States
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Study Endpoints
Primary Endpoints
Percentage change in the magnitude of muscle atrophy
between Day 14 and Day 42
Secondary Endpoints
Percentage change in the magnitude of muscle atrophy, measured by T1W-MRI analysis of the CSA of the triceps surae muscles of the immobilized limb
between Day 14 and Day 42
Percentage change in isometric knee-extension strength (torque), measured by dynamometry
between Day 14 and Day 42
Percentage change in isometric plantar-flexion strength (torque), measured by dynamometry
between Day 14 and Day 42
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BIIB023EXPERIMENTALParticipants receive intravenous (IV) infusions of BIIB023
PlaceboPLACEBO_COMPARATORParticipants receive intravenous (IV) infusions of placebo
Interventions
NameTypeDescription
BIIB023BIOLOGICALIntravenous (IV) infusions
PlaceboBIOLOGICALMatched placebo
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Eligibility Criteria
Age Range18 Years — 35 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Deemed healthy as determined by the Investigator based on medical history, 12-lead electrocardiogram, vital signs, and clinical laboratory parameters at Screening, and physical examination at Baseline * Body mass index (BMI) between 18.5 and 32 kg/m2, inclusive, at the tim...

Countries:United States
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