A First in Human Randomised, Double Blind, Placebo-controlled, Two-part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses (SAD and MAD) of Inhaled ETD001 in Healthy Male and Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Number of participants who discontinue due to an adverse event (AE)
研究概览
简要总结
This is a first in human study of ETD001 a new drug being developed for the treatment of cystic fibrosis. The study is a randomised, placebo-controlled, double-blind interventional study to assess the safety, tolerability and pharmacokinetics of single and multiple ascending doses of inhaled ETD001in healthy male and female subjects.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females using suitable methods of contraception, or females of non-childbearing potential
- •Consent to study participation
- •Body weight ≥ 50 kg and body mass index 19 - 30 kg/m2
- •Vital sign assessments within the normal ranges
- •Healthy as determined following physical and laboratory examinations at screening visit
- •Spirometry readings (FEV1 and FVC) to be ≥ 80% of predicted value
排除标准
- •Acute or chronic illness detected at the screening visit
- •Respiratory tract infection within 4 weeks of the screening visit
- •Use of prescribed or OTC medication within 14 days of the screening visit
- •History of regular alcohol use over the recommended limits within 6 months of screening, or history/evidence of alcohol or drug abuse
- •Smoker or use of tobacco products within 6 months of screening
- •Abnormal blood or urine laboratory test results at screening
- •Recent participation (within 3 months) in another clinical trial
- •Current, or history of, allergy that may be contraindicated
研究组 & 干预措施
Single ascending dose
Single dose of inhaled ETD001/placebo on one occasion
干预措施: ETD001 single dose (Drug)
Single ascending dose
Single dose of inhaled ETD001/placebo on one occasion
干预措施: Placebo single dose (Drug)
Multiple ascending dose (7 days)
Daily doses of ETD001/placebo for 7 consecutive days
干预措施: ETD001 multiple twice daily doses (Drug)
Multiple ascending dose (7 days)
Daily doses of ETD001/placebo for 7 consecutive days
干预措施: Placebo multiple twice daily doses (Drug)
Multiple ascending dose (7 days)
Daily doses of ETD001/placebo for 7 consecutive days
干预措施: ETD001 multiple once daily doses (Drug)
Multiple ascending dose (7 days)
Daily doses of ETD001/placebo for 7 consecutive days
干预措施: Placebo multiple once daily doses (Drug)
Multiple ascending dose (14 days)
Daily doses of ETD001/placebo for 14 consecutive days
干预措施: ETD001 multiple twice daily doses (Drug)
Multiple ascending dose (14 days)
Daily doses of ETD001/placebo for 14 consecutive days
干预措施: Placebo multiple twice daily doses (Drug)
结局指标
主要结局
Number of participants who discontinue due to an adverse event (AE)
时间窗: Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose
时间窗: Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for laboratory assessments at least once post dose
时间窗: Baseline to Week 8
Number of participants reporting one or more treatment emergent adverse event (TEAE)
时间窗: Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose
时间窗: Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for spirometry assessments at least once post dose
时间窗: Baseline to Week 8
次要结局
- Plasma concentrations of ETD001(Day 1 pre-dose and at multiple time-points (up to 14 days) post final dose)