Primary Objective: \- To determine the pharmacokinetics (PK) of a single intravenous (IV) dose of SAR279356 administered to intensive care unit (ICU) patients on mechanical ventilation Secondary Objectives: * To determine the safety and tolerability of SAR279356 * To evaluate the pharmacodynamics (PD) and immunogenicity of SAR279356 * Exploratory efficacy of SAR279356 on prevention of bacterial infections
Total study duration (from screening to last follow-up visit) is 91 days break down as follows: * Screening: 1 day prior to dosing; * Treatment period: one IV injection on Day 1; * Follow-up period: 90 days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
7
Investigational Site Number 840010
Los Angeles, California, United States
Investigational Site Number 840020
Stanford, California, United States
Investigational Site Number 840006
Jacksonville, Florida, United States
Investigational Site Number 840001
Pikeville, Kentucky, United States
Pharmacokinetics parameters of SAR279356 : Ceoi, AUClast and CL
Time frame: 90 days
Opsonophagocytic assay (OPA)
Time frame: 90 days
Opsonophagocytic killing assay (OPK)
Time frame: 90 days
Dosage of human anti-human antibodies (HAHA)
Time frame: 90 days
Occurrence of infections
Time frame: Up to 28 days
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Investigational Site Number 840009
Butte, Montana, United States
Investigational Site Number 840003
Camden, New Jersey, United States