Pharmacokinetics, Pharmacodynamics and Safety Evaluation of SAR279356 in Intensive Care Unit Mechanically Ventilated Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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A Randomized, Double-blind, Placebo-controlled Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of a Single Dose of SAR279356 in Patients Hospitalized in Intensive Care Unit and on Mechanical Ventilation

Conditions
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Infection Prophylaxis

Intervention / Treatment
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* Drug: SAR279356
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : ICU patients on mechanical ventilation at the time of randomization Patients or legally authorized representative (LAR) giving written informed consent. Exclusion criteria: Patients <18 years of age; Documented Pseudomonas infection or colonization in the last 30 days; Immunocompromised patients Hypersensitivity to the study drug and/or to prior therapy with monoclonal antibodies; Patient who has taken other investigational drugs or prohibited therapy for this study within 1 month or 5 half-lives, whichever is longer; Patient or LAR who withdraws consent during the screening (starting from signed informed consent form); Acute liver injury related criteria at the time of study entry: Pregnant or breast-feeding women The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAR279356 dose 1<br>SAR279356 dose 1, single administration | Drug: SAR279356<br>* Pharmaceutical form: solution for infusion Route of administration: intravenous infusion<br>|
| Experimental: SAR279356 dose 2<br>SAR279356 dose 2, single administration | Drug: SAR279356<br>* Pharmaceutical form: solution for infusion Route of administration: intravenous infusion<br>|
| Placebo Comparator: Placebo<br>Matching placebo, single administration | Drug: placebo<br>* Pharmaceutical form: solution for infusion Route of administration: intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics parameters of SAR279356 : Ceoi, AUClast and CL |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opsonophagocytic assay (OPA) |  | 90 days | 
| Opsonophagocytic killing assay (OPK) |  | 90 days | 
| Dosage of human anti-human antibodies (HAHA) |  | 90 days | 
| Occurrence of infections |  | Up to 28 days |