EUCTR2017-004919-39-DE进行中（未招募）1 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)
itto Denko Corporation0 个研究点目标入组 120 人开始时间: 2018年7月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 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.
- •Other protocol defined inclusion/exclusion criteria could apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
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
- •Receiving an investigational treatment, whether or not approved for marketing, with the last dose of that study drug within 8 weeks or 5 half-lives (whichever is longer) before screening. Individuals allocated to receive no treatment beyond SOC in an investigational study are not excluded from this trial.
- •Pregnant or breastfeeding.
- •Known history of HIV infection, active chronic hepatitis B (eg hepatitis B surface antigen positive), and/or untreated hepatitis C antigen positive patients (with or without abnormal liver enzymes). If treated for hepatitis C viral eradication, then a viral load below the limits of quantitative detection for at least 12 weeks must be documented.
- •History of alcohol abuse and/or dependence within the last 2 years.
- •History within the last 2 years of significant mental illness, or dependence on any opioid or illicit drugs, as defined in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- •Suspected or confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, defined as meeting one or more of the following criteria:
- •a. The subject has known exposure to a person with signs or symptoms of SARS-CoV-2 infection or has tested positive for SARS-CoV-2 (suggesting current infection) within 21 days prior to the subject’s Visit 1a.
- •b. The subject has current signs and symptoms suggestive of SARS-CoV-2 infection.
- •c. The subject has SARS-CoV-2 virus or viral antigen detected at Visit 1a using a test approved for marketing if testing is available. (Detection of antibody to SARS-CoV-2 will not be exclusionary).
- •Other protocol defined inclusion/exclusion criteria could apply
研究者
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