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

Phase 2

Terminated

• Conditions: Infection Prophylaxis
• Interventions: Drug: placebo; Drug: SAR279356

• Registration Number: NCT01389700
• Lead Sponsor: Sanofi

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

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 Timeline

• Study First Submitted: 2011-07-06
• Study First Submitted QC: 2011-07-06
• Study First Posted: 2011-07-08
• Study Start: 2011-10
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Disposition First Submitted: 2014-03-17
• Disposition First Submitted QC: 2014-03-17
• Disposition First Posted: 2014-04-14
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-25
• Last Update Posted: 2014-12-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Matching placebo, single administration
SAR279356 dose 1	SAR279356	SAR279356 dose 1, single administration
SAR279356 dose 2	SAR279356	SAR279356 dose 2, single administration

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics parameters of SAR279356 : Ceoi, AUClast and CL	90 days

Secondary Outcome Measures

Name	Time	Method
Occurrence of infections	Up to 28 days
Dosage of human anti-human antibodies (HAHA)	90 days
Opsonophagocytic assay (OPA)	90 days
Opsonophagocytic killing assay (OPK)	90 days

Trial Locations

Locations (6)

Investigational Site Number 840010; 🇺🇸 Los Angeles, California, United States

Investigational Site Number 840020; 🇺🇸 Stanford, California, United States

Investigational Site Number 840001; 🇺🇸 Pikeville, Kentucky, United States

Investigational Site Number 840006; 🇺🇸 Jacksonville, Florida, United States

Investigational Site Number 840009; 🇺🇸 Butte, Montana, United States

Investigational Site Number 840003; 🇺🇸 Camden, New Jersey, United States