ACTRN12621000607875已完成1 期
A randomised, double blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending, intranasal INNA-051 doses in healthy adults.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 76
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
- Randomised controlled trial
- 主要目的
- Prevention
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •1.Healthy adults 18 to less than 65 years of age (Part A and Part B), or 65 to 85 years of age inclusive (Part C) at the time of providing written informed consent.
- •2.Agree to the contraception requirements specified in protocol
- •3.Healthy, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- •4.Body weight at least 50 kg and body mass index (BMI) within the range 18 – 34.9 kg/m2 (inclusive).
- •5.Participants with screening forced expiratory volume in one second (FEV1) at least 80% of the predicted value.
- •6.Willing and able to comply with the study requirements.
排除标准
- •1.History or findings on physical examination of any significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, influence the results of the study or the subject’s ability to participate in the study.
- •2.Clinically significant laboratory assessments at Screening or Day -1
- •3.Pregnant or breast feeding
- •4.Chronic tobacco use or vaping within 60 days prior to screening, and/or positive urine cotinine and/or exhaled carbon monoxide test at check-in.
- •5.Current diagnosis of asthma.
- •6.Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, other nasal malformations, or history of frequent nosebleeds.
- •7.History within 30 days prior to informed consent of active rhinitis, including allergic, non-allergic rhinitis and rhinosinusitis
- •8.Participants with nasal symptoms of upper respiratory tract infection within the 3 weeks prior to screening or baseline. .
- •9. Positive human immunodeficiency virus (HIV), active hepatitis A virus (HAV), hepatitis B virus (HBV), or hepatitis C virus (HCV) test.
- •10.Administration of any intranasal product within the 30 days prior to dosing.
- •11.Use of prescription or non-prescription drugs within 7 days prior to dosing, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise subject safety. NOTE: Part C participants on medications may be included if the medication has been stable for at least 6 weeks prior to screening and is expected to remain stable during the study period.
- •12.Positive drug test or alcohol breath test at screening or Day -1, and/or significant history of alcohol or drug abuse as defined in the protocol.
- •13.Received an investigational product within 30 days or 5 half-lives (whichever is longer) prior to baseline, or concurrent participation in other clinical trials. COVID-19 vaccines will not be exclusionary unless administered intranasally within the 30 days prior to dosing.
- •14.History of drug or other allergy that, in the opinion of the Investigator or Ena Respiratory’s Medical Monitor, contraindicates participation in this study.
- •15.Inability to communicate properly and/or understand the requirements of the study.
- •16.Institutionalised individuals.
研究者
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