SAR156597
DrugPharmaceutical form: solution
Route of administration: subcutaneous
NCT Number: NCT01529853
Primary Objective:
To assess in adult patients with Idiopathic Pulmonary Fibrosis (IPF) the safety and tolerability of ascending doses of SAR156597 administered subcutaneously (SC) once weekly over a 6-week period.
Secondary Objectives:
To assess in adult patients with IPF:
* The pharmacodynamic effects of SAR156597, as measured on pulmonary function tests (PFTs), pulse oximetry and patient reported outcome and peripheral blood biomarkers. * The trough plasma concentrations of SAR156597 * The potential immunogenicity of SAR156597.
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Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Investigational Site Number 124003, Edmonton, Canada
The study consists of a screening period of up to 28 days, treatment period of up to 6 weeks and a post-treatment follow-up period of up to 12 weeks. Total study duration is up to 22 weeks.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Pharmaceutical form: solution
Route of administration: subcutaneous
Pharmaceutical form: solution
Route of administration: subcutaneous
Time frame: from first dose of study drug up to Week 18
Time frame: from baseline to week 6
Time frame: from baseline to week 6
Time frame: from baseline to week 6
Time frame: from baseline to week 18
Time frame: from baseline to week 18
Sanofi
Industry
Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Repeated Doses of SAR156597 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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