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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01389700

Enrollment

Registered

2011-07-08

Start date

2011-10-31

Completion date

2012-12-31

Last updated

2014-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection Prophylaxis

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

Interventions

DRUGSAR279356

Pharmaceutical form: solution for infusion Route of administration: intravenous infusion

DRUGplacebo

Pharmaceutical form: solution for infusion Route of administration: intravenous infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics parameters of SAR279356 : Ceoi, AUClast and CL	90 days

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026