A Placebo-controlled Double-blind Single and Repeated Ascending Dose Study to Investigate the Safety and Tolerability of Inhaled CHF 6001 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
This study is designed to investigate the safety, tolerability and pharmacokinetics of inhaled CHF 6001 after single and multiple doses in healthy volunteers.
详细描述
The study will be conducted in a single centre and will consist of a single dose part and a multiple dose part.
Seven single doses of CHF 6001 will be administered according to an escalation, alternate cross over scheme. Five multiple doses of CHF 6001 will be administered for 7 days according to a sequential escalation scheme.
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
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject's written informed consent obtained prior to any study-related procedure
- •Male healthy volunteers aged 18-55 years;
- •Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly.
- •Body Mass Index (BMI) between 18.0 and 28.0 kg/m2;
- •Non- or ex-smokers who smoked < 5 pack years (pack-years = the number of cigarette packs per day times the number of years) and stopped smoking > 1 year;
- •Results of laboratory tests within the normal ranges. Minor deviations are acceptable provided that they are not judged clinically significant by the investigator.
- •A reliable method of contraception for the subjects and their partner.
排除标准
- •Blood donation or blood loss less than 8 weeks before inhalation of the study medication;
- •Positive HIV1 or HIV2 serology;
- •Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C;
- •History of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen at screening;
- •Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation;
- •Clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol;
- •Treatment within the previous 3 months with any drug known to have a well defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole).
- •Subjects who refuse to abstain from alcohol or caffeine containing foods or beverages or grapefruit containing foods or beverages from 48 hour prior to each intake of study medication until the end of confinement at the clinical centre.
- •Heavy caffeine drinker (> 5 cups or glasses of caffeinated beverages e.g., coffee, tea, cola per day).
研究组 & 干预措施
CHF 6001 SD or placebo
Single administration of CHF 6001 dose levels 1 to 7 or placebo
干预措施: CHF 6001 SD or placebo (Drug)
CHF 6001 MD or placebo
Multiple administration of CHF 6001 dose levels 1 to 5 or placebo
干预措施: CHF 6001 MD or placebo (Drug)
结局指标
主要结局
Body weight
时间窗: After 7 days of treatment
Blood and urine Laboratory tests
时间窗: After 7 days of treatment
Adverse events, adverse drug reactions, serious adverse events.
时间窗: After 7 days of treatment
The number and percentage of subjects with adverse events, adverse drug reactions, serious adverse events
Vital signs
时间窗: After 7 days of treatment
Blood pressure and Heart rate
12-lead ECG
时间窗: After 7 days of treatment
Heart rate, RR, PR, QRS, QT, QTcB, QTcF
24h ECG Holter
时间窗: After 7 days of treatment
Number and percentages of subjects with arrhythmias ( e.g ventricular tachycardia, supra ventricular tachycardia,..)
FEV1
时间窗: After 7 days of treatment
次要结局
- Pharmacokinetics of CHF 6001 and its metabolite(After 7 days of treatment)