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

Sanofi

Status and phase: Terminated; Phase 2

Conditions: Infection Prophylaxis

Treatments: Drug: placebo; Drug: SAR279356

Study type: Interventional

Funder types: Industry

Identifiers

NCT01389700

PKD11791

U1111-1118-6717 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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7 participants in 3 patient groups, including a placebo group

SAR279356 dose 1

Experimental group

Description:

SAR279356 dose 1, single administration

Treatment:

Drug: SAR279356

SAR279356 dose 2

Experimental group

Description:

SAR279356 dose 2, single administration

Treatment:

Drug: SAR279356

Placebo

Placebo Comparator group

Description:

Matching placebo, single administration

Treatment:

Drug: placebo