A single, ascending-dose design with five dose-cohorts of 8 subjects. Forty healthy adults aged 18 to 45, inclusive, will be recruited and admitted at multiple sites. Each subject will be randomized to receive either SAR440894 or matching placebo via 60-minute intravenous infusion. In each cohort of 8 subjects, the randomization ratio will be 6 active to 2 placebo, and 2 sentinel subjects (one from each active and placebo group) will be dosed first. Dosing of the next dose-cohort will be dependent on acceptable meeting predefined safety criteria in the preceding cohort. Each subject's participation will take place over approximately 150 days, not including the screening visit. There are no hypotheses for this phase I study. The primary objective will be to determine the safety of single ascending intravenous (IV) infusions of SAR440894 when administered in healthy adults.
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Frequency of Adverse Events (AEs)
Timeframe: Day 1 through Day 150
Frequency of Serious Adverse Events (SAEs)
Timeframe: Day 1 through Day 150
Frequency of Clinically Significant Vital Signs Results
Timeframe: Day 1 through Day 150
Frequency of Clinically Significant Chemistry Laboratory Results
Timeframe: Day 1 through Day 150
Frequency of Clinically Significant Hematology Laboratory Results
Timeframe: Day 1 through Day 150
Frequency of Clinically Significant Coagulation Laboratory Results
Timeframe: Day 1 through Day 150
Frequency of Clinically Significant Urinalysis Laboratory Results
Timeframe: Day 1 through Day 150
Frequency of Clinically Significant Electrocardiogram (ECG) Results
Timeframe: Day 1 through Day 150