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SAR228810

Phase 1

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

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

Clinical trial landscape

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 used for?

SAR228810 is an investigational small molecule being developed for the treatment of Alzheimer's Disease. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under study to evaluate its safety and pharmacokinetic profile in patients.

Who is developing SAR228810?

SAR228810 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. The company is conducting clinical research on this drug candidate for Alzheimer's Disease, with the drug currently in Phase 1 development.

What phase is SAR228810 in?

SAR228810 is in Phase 1 clinical development. This is the earliest stage of human testing, focused primarily on assessing the drug's safety, tolerability, and how it is absorbed and processed by the body. The drug is investigational and has not yet been approved for any use.

What clinical trials has SAR228810 been in?

SAR228810 has been studied in one completed clinical trial registered under the identifier NCT01485302. This was a single and repeated dosing study designed to assess the safety and concentration-time profile of SAR228810 in patients with Alzheimer's Disease. The trial enrolled 48 participants across multiple countries.

Was the SAR228810 clinical trial randomized and controlled?

Yes, the completed Phase 1 trial of SAR228810 was a randomized, double-blind, controlled study. This design means participants were randomly assigned to receive either the drug or a control, and neither the participants nor the researchers knew who received which treatment during the trial, helping to reduce bias in the results.

Where was the SAR228810 clinical trial conducted?

The Phase 1 clinical trial of SAR228810 was conducted in multiple countries, including Bulgaria, France, Netherlands, South Africa, and Sweden. The study enrolled 48 participants, all of whom were patients with Alzheimer's Disease aged 50 years or older. The trial has been completed.