ACTRN12615000984594已完成1 期
Randomised, double-blind, placebo-controlled Phase I study to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of orally inhaled PB01 administered to healthy subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
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
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- Male
入选标准
- •Able to speak, read and understand English sufficiently to understand the purposes and risks of the study and to provide written informed consent.
- •Healthy males aged 18 to 55 years inclusive at the time of consent.
- •Body Mass Index (BMI) of greater than or equal to 18 to less than or equal to 30.0 kg/m2
- •Normal pulmonary function and performance on pulmonary function tests, defined as Forced expiratory volume measured in one second, expressed in litres (FEV1), and Forced vital capacity, expressed in litres (FVC) both greater than or equal to 80% of their predicted value for age, ethnicity, sex and height.
- •Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- •Participants must be willing to comply with the medically acceptable contraceptive requirements of the study from Screening to at least 30 days after the last IMP administration.
排除标准
- •Participants will not be eligible to participate in the study if they meet any of the following criteria:
- •Clinically significant disease including airway inflammation, haemoptysis or other respiratory disease (except for completely-resolved childhood asthma and symptom free for greater than 5 years).
- •Participants who have a positive urine cotinine test at Screening or Day -1.
- •Smokers (i.e. cigarette or tobacco use at any time within the last 18 months).
- •Use of caffeine-containing foods/beverages/dietary supplements, decaffeinated beverages or alcohol within 48 hours prior to all visits and/or unable to refrain from their use during the study.
- •Use of prescription or non-prescription (over-the-counter) or complementary medicines, within 14 days prior to Day -1, except occasional use of paracetamol (up to 2g per day).
- •Respiratory tract infection within the previous four weeks or any infection within 7 days prior to Day -1.
- •Any clinically significant abnormalities on clinical chemistry, haematology, urinalysis, physical examination, medical history, 12-lead electrocardiogram (ECG), or vital signs as judged by the investigator or sponsor (at Screening and/or Day -1).
- •Clinically significant abnormality of renal function, defined as Cockcroft Gault creatinine clearance less than 70 ml/min.
- •Clinically significant abnormality of hepatic function defined as AST or ALT greater than 1.5 times the upper limit of normal.
- •History or evidence of, or positive test for HIV, hepatitis B or hepatitis C.
- •Positive urine drug screen or alcohol test during Screening or on-study, or history of drug or alcohol abuse and/or dependence within the past year prior to Day -1.
- •Participation in another clinical trial or administration of any investigational agent within 8 weeks or 5 half-lives (whichever is longer) prior to Day -1.
- •History of clinically significant allergic disease requiring medical treatment with medications as judged by the investigator or sponsor.
- •History of hypersensitivity to follistatin or drugs of the same pharmacological class.
- •Surgical or medical conditions which could significantly alter drug absorption, distribution, metabolism or excretion.
- •Major surgery within 3 months prior to Day -1 or anticipated surgery in the study period.
- •Blood or plasma donation of more than 500 mL during the 3 months prior to Day -1.
- •History of or current clinically-significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunological, neurological, ophthalmological, haematological or psychiatric disorder or any other condition, which in the opinion of the investigator or sponsor would jeopardize the safety of the participant or the validity of the study results.
- •Unable to refrain from strenuous activity for 48 hours prior to all visits and for the duration of the study.
- •Unable to use nebuliser.
- •An employee of the sponsor or research site personnel directly affiliated with this study or their immediate family members defined as a spouse, parent, sibling, or child, whether biological or legally adopted.
研究者
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