NL-OMON36629已完成不适用
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 - PRM-151 and IPF patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •IPF patients
- •Age: 40 - 80 yrs (limits included)
- •BMI: 16-33 kg/m2
- •Body weight: >= 50 kg and <= 75 kg (The upper weight limit of <= 75 kg may be
- •increased or decreased depending upon the availability of test article.)
- •FVC >= 45%, corrected for age
- •DLCO: 35 to 80%
排除标准
- •History of amyloidosis, tuberculosis, cystic fibrosis, sarcoidosis or any other pulmonary disease other than IPF.
- •History of connective tissue disorder, severe pulmonary hypertension or COPD with an extent of emphysema
- •greater than the fibrosis.
- •Acute disease state.
研究者
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