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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Infection Prophylaxis	Drug: SAR279356; Drug: placebo	Phase 2

Detailed Description:

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	7 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	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
Study Start Date :	October 2011
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	December 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: SAR279356 dose 1; SAR279356 dose 1, single administration	Drug: SAR279356; Pharmaceutical form: solution for infusion Route of administration: intravenous infusion
Experimental: SAR279356 dose 2; SAR279356 dose 2, single administration	Drug: SAR279356; Pharmaceutical form: solution for infusion Route of administration: intravenous infusion
Placebo Comparator: Placebo; Matching placebo, single administration	Drug: placebo; Pharmaceutical form: solution for infusion Route of administration: intravenous infusion

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Pharmacokinetics parameters of SAR279356 : Ceoi, AUClast and CL [ Time Frame: 90 days ]

Secondary Outcome Measures :

1. Opsonophagocytic assay (OPA) [ Time Frame: 90 days ]
2. Opsonophagocytic killing assay (OPK) [ Time Frame: 90 days ]
3. Dosage of human anti-human antibodies (HAHA) [ Time Frame: 90 days ]
4. Occurrence of infections [ Time Frame: Up to 28 days ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Locations

United States, California
Investigational Site Number 840010
Los Angeles, California, United States, 90024
Investigational Site Number 840020
Stanford, California, United States, 94305
United States, Florida
Investigational Site Number 840006
Jacksonville, Florida, United States, 32209
United States, Kentucky
Investigational Site Number 840001
Pikeville, Kentucky, United States, 41501
United States, Montana
Investigational Site Number 840009
Butte, Montana, United States, 59701
United States, New Jersey
Investigational Site Number 840003
Camden, New Jersey, United States, 08103

Sponsors and Collaborators

Sanofi

Investigators

Study Director:	Clinical Sciences & Operations	Sanofi

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT01389700 History of Changes
Other Study ID Numbers:	PKD11791; U1111-1118-6717 ( Other Identifier: UTN )
First Posted:	July 8, 2011
Last Update Posted:	December 12, 2014
Last Verified:	November 2014