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BIIB033

Phase 1

Central Nervous System (CNS) Demyelinating Disease | Monoclonal antibody | Immunology |Biogen Inc.|Last Updated: Oct 10, 2016

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02641041Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BIIB033 in Healthy Japanese ParticipantsPHASE1 COMPLETED 24 — — Feb 1, 2016Sep 1, 2016Oct 10, 20161 United Kingdom
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Study Endpoints
Primary Endpoints
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Up to day 113
Number of participants with clinically significant laboratory parameters
Up to day 113
Number of participants with clinically significant vital sign abnormalities
Up to day 113
Number of participants with clinically significant electrocardiograms (ECGs) abnormalities
Up to day 113
Number of participants with clinically significant physical examination abnormalities
Up to day 113
Number of participants with clinically significant neurological examination abnormalities
Up to day 113
Secondary Endpoints
PK parameter of BIIB033: Area under the concentration-time curve from time zero to infinity (AUCinf)
Up to day 113
PK parameter of BIIB033: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)
Up to day 113
PK parameter of BIIB033: AUC over a given dosing interval
Up to day 113
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALA single IV dose of 10 mg/kg BIIB033 or placebo given on Day 1
Cohort 2EXPERIMENTALA single IV dose of 30 mg/kg BIIB033 or placebo given on Day 1
Cohort 3EXPERIMENTALOne IV dose of 100 mg/kg BIIB033 or placebo given on Days 1 and 15
Interventions
NameTypeDescription
BIIB033BIOLOGICALsingle or multiple dose
PlaceboOTHERsingle or multiple dose
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Eligibility Criteria
Age Range20 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Japanese subjects must have been born in Japan, and their biological parents and grandparents must all have been of Japanese origin. * Subjects who have lived out of Japan for more than 5 years must not have significantly modified their diets since leaving Japan. * Must be...

Countries:United Kingdom
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