NCT03727802已完成1 期
TRK-250 - A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Inhaled Dose, Safety, Tolerability, and Pharmacokinetic Study of TRK-250 in Subjects With Idiopathic Pulmonary Fibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 11
- 主要终点
- Incidence and Severity of Adverse Events
研究概览
简要总结
TRK-250 is a nucleic acid medicine that inhibits the progression of pulmonary fibrosis by selectively suppressing the expression of transforming growth factor-beta 1 (TGF-β1) protein, at the gene expression level. This study is a double-blind, randomized, placebo-controlled Phase I study. The primary objective of the study is to assess the safety and tolerability of single and multiple inhaled doses of TRK-250 in subjects with idiopathic pulmonary fibrosis (IPF).
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
- •Clinical, radiographic, and histologic features consistent with the diagnosis of IPF
- •SpO2 ≥90% at rest by pulse oximetry while breathing ambient air.
- •FVC ≥50% of predicted.
- •FEV1 ≥50% of predicted.
- •Ratio of FEV1 to FVC ≥0.
- •DLCO corrected for hemoglobin 30% to 79% of predicted, inclusive.
排除标准
- •History of acute exacerbation of IPF or respiratory tract infection within 3 months prior to Screening.
- •Planned surgery during the study.
- •History of malignant tumor within 5 years prior to Screening.
- •History of emphysema or clinically significant respiratory diseases (other than IPF).
- •Other known causes of interstitial lung disease (eg, drug toxicities, environmental exposures, connective tissue diseases).
- •End-stage fibrotic disease expected to require organ transplantation within 6 months.
- •Taking a systemic corticosteroid, cytotoxic therapy, vasodilator therapy for pulmonary hypertension, or unapproved treatment for IPF within 4 weeks prior to Screening. (Treatment with pirfenidone or nintedanib, though not both concurrently, is permitted, provided that the subject has been on a stable dose for at least 4 weeks prior to Screening and it is anticipated the dose will remain unchanged throughout enrollment.)
研究组 & 干预措施
TRK-250
Experimental
干预措施: TRK-250 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and Severity of Adverse Events
时间窗: Up to 14 days after last dose
Number of patients reporting Adverse Events Number of patients by severity reporting Adverse Events
次要结局
未报告次要终点
研究者
研究点 (11)
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