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Clinical Trials/NCT01485302
NCT01485302
Completed
Phase 1

A Multi-center, Parallel-group, Double-blind, Placebo-controlled Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability and the Pharmacokinetic Properties of SAR228810 Given as IV Infusion or as SC Injection in Patients With Mild to Moderate Alzheimer's Disease.

Sanofi8 sites in 5 countries48 target enrollmentJanuary 2012
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ConditionsAlzheimer's Disease
InterventionsSAR228810
DrugsSAR228810

Overview

Phase
Phase 1
Intervention
SAR228810
Conditions
Alzheimer's Disease
Sponsor
Sanofi
Enrollment
48
Locations
8
Primary Endpoint
number of patients with adverse events
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

Primary Objective:

  • To assess the safety and tolerability of escalating single and multiple doses of SAR228810 in patients with Alzheimer's disease (AD)

Secondary Objective:

  • To evaluate the pharmacokinetic properties of SAR228810 after escalating single and multiple doses of SAR228810 in AD patients

Detailed Description

14.5 to 22 months

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
February 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sanofi
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Cohort 1

Dose 1 IV infusion

Intervention: SAR228810

Cohort 2

Dose 2 IV infusion

Intervention: SAR228810

Cohort 3

Dose 3 IV infusion

Intervention: SAR228810

Cohort 4

Dose 4 IV infusion

Intervention: SAR228810

Cohort 5

Dose 1 SC injection

Intervention: SAR228810

Cohort 6

Dose 2 SC injection

Intervention: SAR228810

Outcomes

Primary Outcomes

number of patients with adverse events

Time Frame: 10 months

Secondary Outcomes

  • Cmax(1 to 112 days after dosing)
  • t1/2z(1 to 112 days after dosing)
  • brain magnetic resonance imaging(10 months)
  • hematology, biochemistry, coagulation(10 months)
  • vital signs, ECG(10 months)
  • AUC(1 to 112 days after dosing)

Study Sites (8)

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