A Randomized, Double-Masked, Sponsor-Unmasked, Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRM-151 Administered Intravenously to Patients With Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 5
- 主要终点
- Safety and Tolerability
研究概览
简要总结
The aims of the study are to assess safety, tolerability, the pharmacokinetic profile, and the pharmacodynamic profile of multiple doses of PRM-151 administered IV to IPF patients.
详细描述
Idiopathic pulmonary fibrosis (IPF) is a diffuse lung disease with a histological picture of usual interstitial pneumonia and a deteriorating clinical course. The prognosis is poor. Chronic alveolar inflammation with associated parenchymal remodeling is theorized to promote an ongoing abnormal fibrogenic repair response. Corticosteroids and immunomodulatory agents have not been shown to benefit IPF patients. Recently several published clinical studies have indicated a strong correlation between IPF severity and/or disease progression and the levels of specific plasma biomarker proteins related to epithelial cell health and extracellular matrix turnover.
PRM-151 is being developed for potential therapeutic uses to prevent, treat, and reduce fibrosis.
This study is the first intravenous multiple-dose study in humans, and will be conducted in patients with IPF. Patients will be randomized to receive either PRM-151 or placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women of non-childbearing potential aged 40 to 80 years at screening.
- •Diagnosis of idiopathic pulmonary fibrosis (IPF) as determined by high resolution computerized tomography (HRCT) and pulmonary function tests.
排除标准
- •History or presence of connective tissue disorder, tuberculosis (TB), cystic fibrosis, sarcoidosis, amyloidosis or other pulmonary disease except idiopathic pulmonary fibrosis (IPF).
- •History or presence of chronic pulmonary obstructive disease, severe pulmonary hypertension, drug-induced pulmonary toxicity, other forms of idiopathic pneumonia, or interstitial lung diseases associated with environmental exposure medication or systemic disease.
- •High resolution computerized tomography (HRCT) findings inconsistent with idiopathic pulmonary fibrosis(IPF).
结局指标
主要结局
Safety and Tolerability
时间窗: From first dose on Day 1 through Day 57
Number of subjects with Dose Limiting Toxicities, Number of Treatment Emergent Serious Adverse Events and Adverse Events
次要结局
- Cmax(Day 15)
- Tmax(Day 15)
- AUC48(Day 15)
- Total Body Clearance(Day 15)
- Terminal Elimination Half Life(Day 15)
- Vss(Day 15)
- FEV1 (Forced Expiratory Volume 1sec )(%) Change From Baseline(Day 1 (Baseline) and Day 57)
- FVC (Forced Vital Capacity) Change From Baseline to Day 57(Change from Day 1 (Baseline) to Day 57)
- FVC (Forced Vital Capacity) % Predicted Change From Baseline(Day 1 (Baseline) and Day 57)
- DLCO (%) (Diffusing Capacity of Carbon Monoxide) Change From Baseline(Day 1 (Baseline) and Day 57)
- 6MWT (6 Minute Walk Test) Distance Walked Change From Baseline(Screening (between Day -35 and Day 1) and Day 57)
- SGRQ (St. George's Respiratory Questionnaire) Total Score Change From Baseline(Day 1 (Baseline) and Day 57)