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

Sponsor

Sanofi (Industry)

Overall Status

Terminated

CT.gov ID

NCT01389700

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

1.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Oct 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

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

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

Primary Outcome Measures

Pharmacokinetics parameters of SAR279356 : Ceoi, AUClast and CL [90 days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site Number 840010	Los Angeles	California	United States	90024
2	Investigational Site Number 840020	Stanford	California	United States	94305
3	Investigational Site Number 840006	Jacksonville	Florida	United States	32209
4	Investigational Site Number 840001	Pikeville	Kentucky	United States	41501
5	Investigational Site Number 840009	Butte	Montana	United States	59701
6	Investigational Site Number 840003	Camden	New Jersey	United States	08103

Sponsors and Collaborators

Sanofi

Investigators

Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sanofi

ClinicalTrials.gov Identifier:

NCT01389700

Other Study ID Numbers:

PKD11791
U1111-1118-6717

First Posted:

Jul 8, 2011

Last Update Posted:

Dec 12, 2014

Last Verified:

Nov 1, 2014

Study Results

No Results Posted as of Dec 12, 2014