ACTRN12617000854336已完成1 期
A Phase 1, Open-Label Study, to Evaluate the Safety and Tolerability of multiple inhalation of SM04646 Inhalation Solution in Subjects with Mild to Moderate Idiopathic Pulmonary Fibrosis (IPF)
Samumed Pacific Pty Ltd0 个研究点目标入组 10 人开始时间: 2017年6月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 40 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Diagnosis of Idiopathic pulmonary fibrosis (IPF)
- •- Forced vital capacity (FVC) greater than or equal to 50%
- •- Lung diffusing capacity (DLCO) greater than or equal to 35%
- •- FEV1/FVC greater than or equal to 0.70 after administration of a bronchodilator
- •- Resting O2 saturation greater than or equal to 90% after 10 minutes at rest on room air
- •- Full understanding of the requirements of the study and willingness and ability to comply with all study visits and procedures
- •- Able to comprehend and willing to sign an informed consent form (ICF)
- •- Able to tolerate and complete placebo (vehicle) inhalation
排除标准
- •- Women who are pregnant or lactating
- •- Women who are not post-menopausal who are sexually active and are not willing to use birth control
- •- Males who are sexually active and not willing to use a condom
- •- Males unwilling to refrain from sperm donation
- •- Subjects unwilling to refrain from blood and plasma donation
- •- A history of abuse of prescription or illicit drugs
- •- Positive urine drug screen
- •- Recent occurrence of serious illness requiring hospitalization
- •- Current smoker, or recent history of smoking
- •- Recent use of non-inhaled tobacco- or nicotine-containing products
- •- Regular alcohol abuse
- •- Known hypersensitivity to the active substance or any excipients
- •- Lung transplantation anticipated during the duration of the trial
- •- Receipt of any of the following medication or treatment:
- •a. Nintedanib or Pirfenidone within 7 days prior to screening
- •b. Previous therapeutic radiation treatment of the lungs, mediastinum, or chest wall
- •c. Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure
- •d. Immunosuppressive medications
- •e. Use of any therapy targeted to treat IPF
- •f. Use of any cytokine modulator
- •g. Recent use of a bronchodilator
- •- History of any of the following conditions:
- •a. Pulmonary embolism or pulmonary hypertension
- •b. Poor creatinine clearance
- •c. Active TB infection or history of incompletely treated latent TB infection
- •d. History of malignancy within the last 5 years
- •e. Connective tissue disease
- •f. Congenital respiratory conditions
- •g. Chronic obstructive pulmonary disease (COPD) or asthma
- •h. Recent respiratory tract infection
- •i. Recent acute exacerbation of IPF
- •j. HIV, hepatitis C, or active hepatitis B infection
- •k. Hepatic cirrhosis
- •l. Recent symptomatic coronary artery disease or myocardial infarction (MI)
- •m. Hypertension
- •n. Hypotension
- •o. Any condition that is dependent on oxygen therapy
- •- Any condition that constitutes a risk or contraindication for participation
- •- Abnormal haematology values or blood chemistry values
- •- History of cardiac arrhythmia
- •- Subjects who are immediate family members of personnel directly affiliated with the study at the
- •investigative site, or are directly affiliated with the study at the investigative site
- •- Subjects employed by Samumed Pacific Pty Ltd, or any of its affiliates or development partners
- •(responsible for the conduct of the study)
- •- Subjects who are immediate family members of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site
- •- Subjects employed by Samumed Pacific Pty Ltd, or any of its affiliates or development partners responsible for the conduct of the study
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