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)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 24
- 试验地点
- 21
- 主要终点
- Safety/tolerability: Number of participants with Adverse events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SAR156597 dose 1
SAR156597 dose 1, subcutaneous injection once every week
干预措施: SAR156597 (Drug)
SAR156597 dose 2
SAR156597 dose 2, subcutaneous injection once every week
干预措施: SAR156597 (Drug)
SAR156597 dose 3
SAR156597 dose 3, subcutaneous injection once every week
干预措施: SAR156597 (Drug)
Placebo
Placebo (for SAR156597), subcutaneous injection once every week
干预措施: Placebo (for SAR156597) (Drug)
结局指标
主要结局
Safety/tolerability: Number of participants with Adverse events
时间窗: from first dose of study drug up to Week 18
次要结局
- Pharmacodynamic: Change in plasma levels of biomarkers(from baseline to week 18)
- Pharmacokinetic: SAR156597 plasma concentration(from baseline to week 18)
- Pharmacodynamic: Change in forced (expiratory) vital capacity (FVC)(from baseline to week 6)
- Pharmacodynamic: Change in carbon monoxide diffusing lung capacity (DLco)(from baseline to week 6)
- Pharmacodynamic: Change in Saint George Respiratory Questionnaire (SGRQ)(from baseline to week 6)