NCT07055321已完成1 期
A Phase 1, First-in-human, Randomized, Participant- and Investigator-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of ETH47 in Healthy Participants
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Ethris GmbH
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Number of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics and target engagement of ETH47 in healthy participants following single intranasal and single inhaled administration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- All
- 接受健康志愿者
- 是
入选标准
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF), restriction handbook and in this protocol.
- •Participants who are overtly healthy, as determined by screening assessments and the Investigator's judgement, aged ≥18 and ≤55 years at the time of obtaining informed consent.
- •Body mass index of 18.5 to 32 kg/m2 (inclusive).
- •Participants must agree to use contraception methods.
- •Parts B only: participants must be able to perform reliable and reproducible pulmonary function tests and meet the following criteria at screening:
- •Forced expiratory volume in one second (FEV1) ≥80 % predicted by third National Health and Nutrition Examination Survey standards, and
- •Change in FEV1 and forced vital capacity <200 mL, 15 minutes after 4 puffs of inhaled short-acting beta 2-agonists.
排除标准
- •History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, autoimmune, or immunosuppressive disorders which, in the Investigator's judgement, puts the participant at risk due to participation in the trial, may influence the results of the trial, or the subject's ability to participate in the trial.
- •Signs or symptoms of upper or lower respiratory tract infection within 2 weeks of randomisation.
- •Participants who are SARS-CoV-2 positive.
- •Known or positive laboratory results at screening for human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C.
- •Any malignancy except for the following:
- •Adequately treated basal cell carcinoma or
- •History of any other cancer where the disease-free period is ≥5 years.
- •The evidence of any other active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, haematology, blood chemistry, serology, and urinalysis.
研究组 & 干预措施
Part A-5
Experimental
干预措施: ETH47 (Drug)
Part B-1
Experimental
干预措施: ETH47 (Drug)
Part B-2
Experimental
干预措施: ETH47 (Drug)
Part B-3
Experimental
干预措施: ETH47 (Drug)
Part B-4
Experimental
干预措施: ETH47 (Drug)
Part A-4
Experimental
干预措施: ETH47 (Drug)
Part A-1
Experimental
干预措施: ETH47 (Drug)
Part A-2
Experimental
干预措施: ETH47 (Drug)
Part A-3
Experimental
干预措施: ETH47 (Drug)
结局指标
主要结局
Number of treatment-emergent adverse events (TEAEs)
时间窗: From treatment until end of study (d 21)
Number of serious adverse events (SAEs)
时间窗: From enrollment until end of study (day 21)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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