jRCT2080225045已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Biological Activity, and PK of ND-L02-s0201 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Proportion of Participants Discontinuing Study Treatment Due to TEAEs
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter, International, Double-Blind, Randomized
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 40age old over 至 80age old under（—）
- 性别
- All
入选标准
- •Forced vital capacity (FVC) >= 45% of predicted.
- •Diffusion capacity of the lung for carbon monoxide (DLco) corrected for hemoglobin >= 30% of predicted value
- •Ratio of forced expiratory volume in 1 second (FEV1) to FVC >= 0.70.
排除标准
- •Best, acceptable FVC from separate screening spirometry that differ by >= 200 mL.
- •Respiratory exacerbation(s) or hospitalization for IPF exacerbation within 3 months before screening.
- •Anticipated to receive a lung transplant during the subject's participation in the study.
- •Active smoker or smoking cessation within 12 weeks before screening.
- •Malignancy within the last 5 years, with the exception of curable cancer that has received adequate treatment.
- •Evidence of any unstable or untreated, clinically significant disease or condition that, in the opinion of the Investigator, might confound the interpretation of the study or place the subject at increased risk.
- •Treatment with high dose corticosteroids, cytotoxic agents, unapproved IPF targeted therapy, and cytokine modulating agents within 8 weeks or 5 half-lives (whichever is longer) before screening
- •Participation in an investigational study with the last dose of investigational product occurring within 8 weeks or 5 half-lives (whichever is longer) before screening.
- •Pregnant or breastfeeding.
- •Medical history of infection with HIV, hepatitis B, or hepatitis C.
- •History of alcohol abuse and/or dependence within the last 2 years.
- •History within the last 2 years of significant mental illness, or physical dependence on any opioid or illicit drugs.
结局指标
主要结局
Proportion of Participants Discontinuing Study Treatment Due to TEAEs
时间窗: from baseline to 24 weeks
The number of participants with TEAEs leading to discontinuation from the study treatment. The Safety Population (including all participants who received at least one dose of study treatment) is presented. TEAE = treatment-emergent adverse event
次要结局
未报告次要终点
研究者
研究点 (1)
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