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SAR228810

Phase 1

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

SAR228810 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Dec 2011

SAR228810 target and mechanism

Molecular targetprotofibrillar AB
Target classAntibody
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

SAR228810 clinical trials

SAR228810 · 1 trial · 1 indication

Phase 1 1
NCT01485302Single and Repeated Dosing Study to Assess the Safety and the Concentration-time Profile of SAR228810 in Alzheimer's PatientsAlzheimer's Disease
COMPLETED48 Analytics
PHASE1COMPLETED
Single and Repeated Dosing Study to Assess the Safety and the Concentration-time Profile of SAR228810 in Alzheimer's Patients
Alzheimer's DiseaseUnlock trial analytics

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 to 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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Frequently asked questions about SAR228810

What is SAR228810?

SAR228810 is an investigational small molecule developed by Sanofi for Alzheimer's disease. It was studied in a Phase 1 clinical trial evaluating single and repeated dosing in patients with Alzheimer's disease. The program is in early clinical development and is not approved for any indication.

What is SAR228810 used for in Alzheimer's disease?

SAR228810 was being developed as a treatment for Alzheimer's disease. A single Phase 1 trial enrolled 48 Alzheimer's patients to assess safety and the concentration-time profile of single and repeated doses. The study is completed, and the drug remains investigational rather than an approved therapy.

What does SAR228810 target?

SAR228810 targets protofibrillar AB, a form of amyloid beta. The compound is described as a small molecule directed at this protofibrillar AB target. Targeting protofibrillar AB reflects an amyloid-directed approach to Alzheimer's disease, though the clinical program remained at the Phase 1 stage.

Who makes SAR228810?

SAR228810 is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the Phase 1 study of the compound in Alzheimer's disease. The asset sits within Sanofi's neurology pipeline and has not advanced beyond early clinical testing.

What phase is SAR228810 in?

SAR228810 is in Phase 1. One Phase 1 trial has been completed, and no active trials are ongoing. The study was randomized, double-blind, and controlled, enrolling 48 patients. SAR228810 is investigational and has not been approved by the FDA for Alzheimer's disease or any other indication.

What clinical trials is SAR228810 in?

SAR228810 was studied in trial NCT01485302, titled a single and repeated dosing study to assess safety and the concentration-time profile of SAR228810 in Alzheimer's patients. The Phase 1 trial enrolled 48 participants across Bulgaria, France, the Netherlands, South Africa, and Sweden, and it is completed.