ACTRN12616000496415已完成1 期
A Phase I, double-blind, placebo-controlled, randomised, crossover study to assess the anti-inflammatory effects of orally inhaled PB01 following an inhaled lipopolysaccharide (LPS) challenge in healthy male volunteers.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
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 32.0 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, study restrictions, treatment plan, laboratory tests and other study procedures.
- •Participants must be willing not to donate sperm and to comply with the medically acceptable contraceptive requirements of the study from first dose of IMP to 30 days after the last IMP administration.
- •Ability to produce a sputum sample, sufficient to produce at least 50 mg sputum plugs with a viability factor of not less than 40%, total cell count range greater than or equal to 0.50 to less than or equal to 14 x 106 cells per gram, comprising less than or equal to 55% neutrophils, less than or equal to 20% squamous epithelial cells and less than or equal to 3% eosinophils.
排除标准
- •Participants will not be eligible to participate in the study if they meet any of the following criteria:
- •Clinically significant respiratory disease including airway inflammation, haemoptysis or other respiratory disease (except for completely-resolved childhood asthma and symptom free for greater than 5 years).
- •Current smokers or ex-smokers who have given up smoking for less than 12 months and/or have a smoking pack history of greater than 5 pack years (1 pack year equals 20 cigarettes per day for 1 year or 5 cigarettes per day for 4 years).
- •Participants with any currently active infection, or who have a previous respiratory tract infection that resolved less than 4 weeks prior to screening or to randomisation, or any other previous infection that resolved less than 7 days prior to screening or to randomisation.
- •Any clinically significant abnormalities on physical examination, medical history, 12-lead electrocardiogram (ECG), or vital signs as judged by the investigator and in consultation with the sponsor if required.
- •Any clinically significant abnormalities on clinical laboratory tests (clinical chemistry, liver function, haematology, coagulation profile and urinalysis) at screening. Note: These screening laboratory samples must be obtained no more than 7 days prior to randomisation.
- •Clinically significant abnormality of renal function, defined as Cockcroft Gault creatinine clearance less than 70 ml/min. Note: These screening laboratory samples must be obtained no more than 7 days prior to randomisation.
- •Clinically significant abnormality of hepatic function defined as AST or ALT greater than 1.5 times the upper limit of normal. Note: These screening laboratory samples must be obtained no more than 7 days prior to randomisation.
- •History or evidence of, or positive test for Hepatitis B, Hepatitis C and HIV.
- •Positive urine drug screen, urine cotinine test or alcohol breath test at screening or prior to randomisation, or a history of drug or alcohol abuse and/or dependence within the past year prior to screening.
- •Administration of any investigational agent within 8 weeks or 5 half-lives (whichever is longer) prior to screening.
- •History of clinically significant allergic disease requiring medical treatment with medications as judged by the investigator and in consultation with the sponsor if required.
- •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 screening or anticipated surgery in the study period.
- •Blood or plasma donation of more than 500 mL during the 3 months prior to screening or randomisation.
- •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 and in consultation with the sponsor if required would jeopardize the safety of the participant or the validity of the study results.
- •History of significant drug hypersensitivity, milk protein allergy, hypersensitivity to inhalation challenges, or any history of anaphylactic reactions.
- •Participants who have undergone an lipopolysaccharide (LPS) challenge within the previous month prior to screening or a history of significant adverse reaction to LPS ch
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