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Aducanumab

Phase 1

Healthy Volunteer | Monoclonal antibody | Other |Biogen Inc.|Last Updated: Apr 18, 2023

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment123
FDA Designations
ACCELERATED_APPROVAL
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05216887A Study to Assess the Pharmacokinetic (PK) Comparability of 2 Fixed Subcutaneous (SC) Doses of Aducanumab (BIIB037) With a Single, Weight-Based Intravenous (IV) Dose in Healthy VolunteersPHASE1 COMPLETED 123 — — Feb 1, 2022Jul 27, 2022Apr 18, 20233 United States
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Study Endpoints
Primary Endpoints
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Aducanumab
Predose and at multiple time points post-dose up to Day 99
Secondary Endpoints
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Up to Day 99
Number of Participants with Clinically Significant Abnormal Vital Sign Values
Up to Day 99
Number of Participants with Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Values
Day 1 and Day 99
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Aducanumab IVACTIVE_COMPARATORParticipants will receive a single weight-based dose of aducanumab via IV infusion on Day 1.
Aducanumab SCEXPERIMENTALParticipants will receive 2 fixed doses of aducanumab via SC injection on Days 1 and 15.
Interventions
NameTypeDescription
AducanumabBIOLOGICALAdministered as specified in the treatment arm.
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Eligibility Criteria
Age Range40 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites3

Key Inclusion Criteria: * Have a body mass index between 18 and 30 kilograms per meter square (kg/m\^2), inclusive * Japanese participant has both biological parents and all 4 grandparents of Japanese descent * Have a negative polymerase chain reaction test result for severe acute respiratory syndr...

Countries:United States
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