DRKS00028033已完成1 期
CoViD-19 treatment by Aloxistatin-Inhalation – a phase I trial to evaluate the safety of inhalable aloxistatin (E64d) - COALITION-I
niversitätsklinikum Freiburg vertreten durch den Leitenden Ärztlichen Direktor und die Kaufmännische Direktorin0 个研究点目标入组 48 人开始时间: 2023年4月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
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
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 64 Years（—）
- 性别
- Male
入选标准
- •1. Signed Informed Consent Form (ICF), including consent to use effective contraceptive methods (sexual abstinence or condoms) during the trial and for three months after the end of the study
- •2. Male subjects
- •3. Electrocardiogram (ECG) without clinically significant abnormalities (including QTc < 450 ms)
- •4. Age = 18 and < 65 years at the time of signing ICF
- •5. Body mass index (BMI) = 18 and = 30
- •6. Normally active and in good health by medical history and physical examination
- •7. FEV1 (one-second capacity) must be greater than or equal to the
- •Lower Limit of Normal, which corresponds to the 5% percentile (zscore
- •of -1.645)
排除标准
- •1. Enrollment in any interventional clinical trial in the previous 6 months
- •2. Healthy volunteers being unable to follow study instructions and not understanding basics and risks of the study
- •3. Underlying condition that may interfere with inhalation of the IMP
- •4. Current acute or chronic condition (including airway infection (cough, purulent sputum), fever, chronic obstructive pulmonary disease (COPD), asthma, or other severe respiratory disease, cardiovascular disease, diabetes mellitus, obesity, malignant and autoimmune diseases) unless considered clinically irrelevant and stable by the investigator
- •5. History of allergies
- •6. Renal insufficiency (estimated glomerular filtration rate [eGFR] < 60 mL/min/1·73m²) or hepatic impairment (as judged by the investigator)
- •7. The presence of a condition which renders the subject vulnerable as defined by good clinical practice (GCP) or of a condition the investigator believes would interfere with the ability to provide informed consent, or comply with study procedures/instructions, or that might confound the interpretation of the study results or put the subject at undue risk
- •8. Anamnestic smoke or regular use of any form of nicotine product including e-cigarette, snuff, chewing tobacco, nicotine gum, etc.,
- •during the study period and for the previous 6 months
- •9. Healthy volunteers unable to abstain from alcoholic drinks during the study, prehistory of or current alcohol or drug abuse
- •10. Known difficulty undergoing venipuncture or poor venous access
- •11. Whole blood donation or loss (> 400 mL) within 90 days before the dosing of Investigational medicinal product (IMP)
- •12. Consumed alcohol in the 4 days prior to dosing
- •13. Anamnestic any therapies within 90 days prior to dosing. Nonprescriptive
- •drugs within 90 days prior to dosing are allowed by investigators judgement.
- •14. Failure to provide contact details of a person with unimpeded access to the trial participant for 24h after inhalation of IMP, who can call for help in case of emergency situations caused by adverse reactions occurring after discharge from the clinic.
研究者
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