Single and Repeated Dosing Study to Assess the Safety and the Concentration-time Profile of SAR228810 in Alzheimer's Patients
- Registration Number
- NCT01485302
- Lead Sponsor
- Sanofi
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 3 SAR228810 Dose 3 IV infusion Cohort 2 SAR228810 Dose 2 IV infusion Cohort 1 SAR228810 Dose 1 IV infusion Cohort 5 SAR228810 Dose 1 SC injection Cohort 4 SAR228810 Dose 4 IV infusion Cohort 6 SAR228810 Dose 2 SC injection
- Primary Outcome Measures
Name Time Method number of patients with adverse events 10 months
- Secondary Outcome Measures
Name Time Method 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 Cmax 1 to 112 days after dosing
Trial Locations
- Locations (8)
Investigational Site Number 250001
🇫🇷Pierre Bénite, France
Investigational Site Number 528001
🇳🇱Leiden, Netherlands
Investigational Site Number 100001
🇧🇬Sofia, Bulgaria
Investigational Site Number 250002
🇫🇷Toulouse Cedex 3, France
Investigational Site Number 752003
🇸🇪Malmö, Sweden
Investigational Site Number 752002
🇸🇪Mölndal, Sweden
Investigational Site Number 752001
🇸🇪Stockholm, Sweden
Investigational Site Number 710001
🇿🇦Bloemfontein, South Africa