ACTRN12615001349538已完成1 期
A Phase 1, Open-Label Study, to Evaluate the Safety and Tolerability of a Single Inhalation of SM04646 Solution in Healthy Subjects
Samumed Pacific Pty Ltd0 个研究点目标入组 17 人开始时间: 2015年12月14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
- 17
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
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •In good general health;
- •Able to comprehend and willing to sign an informed consent form;
- •Able to tolerate and complete placebo (vehicle) inhalation for 10 minutes without experiencing a significant cough
排除标准
- •Women who are pregnant or lactating;
- •Women of childbearing potential who are sexually active and are not willing to use a highly effective method of birth control during the study period;
- •Males who are sexually active and have a partner who is capable of becoming pregnant, neither of whom have had surgery to become sterilized, that are not using a highly effective method of birth control during the study treatment period until 90 days post study medication administration;
- •Males unwilling to refrain from sperm donation during the study treatment period until 90 days post study medication administration;
- •Current smoker, or past history of smoking within 6 months or >10 pack years
- •Receipt of any of the following medication or treatment prior to the Screening Visit:
- •a. Prescription medication within 7 days prior to the Screening Visit, except for prescription birth control
- •b. Previous therapeutic radiation treatment of the lungs, mediastinum, or chest wall
- •c. Current use of NSAIDs or aspirin (within 24 hours of the Screening Visit)
- •d. Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure within 1 month or 5 half-lives of the investigational product, whichever is longer, prior to the Screening Visit;
- •History of any of the following conditions:
- •a. Idiopathic pulmonary fibrosis
- •b. Pulmonary embolism or pulmonary hypertension
- •c. Congenital respiratory conditions (e.g. cystic fibrosis)
- •d. Chronic obstructive pulmonary disease (COPD)
- •e. HIV, hepatitis C, or active hepatitis B infection
- •f. Hepatic cirrhosis
- •g. Lower respiratory tract infection within 30 days prior to the Screening Visit
- •h. Coronary artery disease, congestive heart failure, or myocardial infarction
- •i. Restrictive or obstructive lung disease
- •j. Hypertension
- •k. Hypotension
- •l. Any condition that is dependent on oxygen therapy;
- •Clinically significant abnormal hematology values or blood chemistry values;
- •History of clinically significant cardiac arrhythmia
研究者
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