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NCT01529853 · ClinicalTrials.gov registry record · Phase 1
To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01529853 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 24 participants.
The verdict
NCT01529853, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG SAR156597
- DRUG Placebo (for SAR156597)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-01 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01529853
The ClinicalTrials.gov registry entry for NCT01529853 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SAR156597 is the first listed.
NCT01529853 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01529853 about?
NCT01529853 is a clinical study titled "To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF)". 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...
What is the current status of trial NCT01529853?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-01. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01529853?
The interventions under investigation include: SAR156597 (DRUG), Placebo (for SAR156597) (DRUG).
Who is sponsoring clinical trial NCT01529853?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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