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SAR228810

Phase 1

Alzheimer's Disease | Small molecule | Neurology |Sanofi|Last Updated: Mar 25, 2015

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-BlindCONTROLLED
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01485302Single and Repeated Dosing Study to Assess the Safety and the Concentration-time Profile of SAR228810 in Alzheimer's PatientsPHASE1 COMPLETED 48Jan 1, 2012Feb 1, 2015Mar 25, 20158 Bulgaria, France +3
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Study Endpoints
Primary Endpoints
number of patients with adverse events
10 months
Secondary Endpoints
AUC
1 to 112 days after dosing
Cmax
1 to 112 days after dosing
t1/2z
1 to 112 days after dosing
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALDose 1 IV infusion
Cohort 2EXPERIMENTALDose 2 IV infusion
Cohort 3EXPERIMENTALDose 3 IV infusion
Cohort 4EXPERIMENTALDose 4 IV infusion
Cohort 5EXPERIMENTALDose 1 SC injection
Cohort 6EXPERIMENTALDose 2 SC injection
Interventions
NameTypeDescription
SAR228810DRUGPharmaceutical form:solution Route of administration: intravenous
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Eligibility Criteria
Age Range50 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion criteria: * Male or female patients with mild to moderate Alzheimer's disease, aged between 50 and 85 years inclusive * Meets criteria for probable Alzheimer's of the National Institute of Neurologic and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Associ...

Countries:BulgariaFranceNetherlandsSouth AfricaSweden
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