ACTRN12614001199606已完成1 期
A Phase I study to evaluate the safety, tolerability and pharmacodynamics of inhaled Leukotriene B4 (LTB4) in healthy subjects and in chronically infected bronchiectasis patients
TB4 Sweden AB0 个研究点目标入组 30 人开始时间: 2014年11月14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
- 30
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •PART A – INCLUSION CRITERIA
- •1. Males or females 18 – 70 years of age (inclusive).
- •2.Able to communicate with site personnel and to understand and voluntarily sign the Informed Consent Form.
- •3.Willing and able to comply with the Protocol, including availability for all scheduled study visits.
- •4.Use of effective contraception (A highly effective method of birth control is defined as those which result in a low failure rate(i.e. less than 1 percent per year) when used consistently and correctly), if procreative potential exists.
- •5.Body Mass Index (BMI) of 18 to 30 kg/m2 inclusive and weight up to a maximum of 90 kg inclusive.
- •6.Negative urine screen for drugs of abuse and negative alcohol breath test at screening and prior to dosing.
- •7.In good general health with no clinically significant abnormalities at screening determined by medical history, vital signs, physical examination, serum chemistry, hematology, urinalysis, and 12-lead ECG.
- •PART B – INCLUSION CRITERIA
- •2.Males or females 18 - 75 years of age (inclusive) with a clinical diagnosis of bronchiectasis.
- •3.Able to communicate with site personnel and to understand and voluntarily sign the Informed Consent Form.
- •4.Willing and able to comply with the Protocol, including availability for all scheduled study visits.
- •5.Use of effective contraception (A highly effective method of birth control is defined as those which result in a low failure rate(i.e. less than 1 percent per year) when used consistently and correctly), if procreative potential exists.
- •6.Negative urine screen for drugs of abuse and negative alcohol breath test at screening and prior to dosing
- •7.25% less than FEV1less than 75% of predicted at screening
- •8.Stable” PA present in sputum at screening. Culture proven colonization by PA for at least 3 months prior to screening (i.e. documentation of PA on two or more cultures more than one month apart, including PA at the time of entry into the study).
- •9.Oxygen saturation on room air higher than 92% at screening
排除标准
- •PART A – EXCLUSION CRITERIA
- •1.Participation in another experimental/interventional protocol within 30 days prior to screening.
- •2.Females who are nursing, pregnant or intend to become pregnant or females of childbearing potential who have had a positive pregnancy test during screening evaluation.
- •3.A history of drug or alcohol abuse within one year of study entry. Alcohol abuse is defined as consumption of more than 3 standard drinks per day and not able to abstain from alcohol totally within 24 hours of dose administration until the end of the treatment period.
- •4.Positive human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV) and tuberculosis (TB) screening test results.
- •5.Smokers (ex-smokers who quit smoking must have a one year period of not smoking prior to the Investigational Product administration).
- •6.Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •7.Donation of blood or plasma within one month of Investigational Product administration.
- •8.Subjects who in the opinion of the Investigator are in poor medical or psychiatric risk for therapy with an investigational drug.
- •9.History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past five years, regardless of whether there is evidence of local recurrence or metastases.
- •10.Treatment with any prescription medication and/or non-prescription products including vitamins or mineral supplements within 14 days before Investigational Product administration (with the exception of birth control medications)
- •PART B – EXCLUSION CRITERIA
- •1.Participation in another experimental/interventional protocol within the past 30 days prior to screening.
- •2.Females who are nursing, pregnant or intend to become pregnant or females of childbearing potential who have had a positive pregnancy test during screening evaluation.
- •3.A history of alcohol or drug abuse within one year of study entry. Alcohol abuse is defined as consumption of more than 3 standard drinks per day and not able to abstain from alcohol totally within 24 hours of dose administration until the end of the treatment period.
- •4.Positive HIV, HBV, HCV and TB screening test results.
- •5.Smokers (ex-smokers who quit smoking must have a one year period of not smoking prior to the study drug administration).
- •6.Donation of blood or plasma within one month of Investigational Product administration.
- •7.Subjects who in the opinion of the Investigator are in poor medical or psychiatric risk for therapy with an investigational drug.
- •8.Under treatment for cancer within the previous year.
- •9.Presence of any severe liver disease with cirrhosis, active hepatitis, active chronic hepatitis, alanine transaminase (ALT) or aspartate transaminase (AST) higher than 3 x Upper Limit of Normal (ULN), biliary obstruction with hyperbilirubinemia higher than 2 x ULN.
- •10.Active cholecystitis, gall bladder symptoms or any hepatobiliary abnormalities.
- •11.The presence of severe renal impairment, creatinine clearance (CrCl) less than 30 ml/min or creatinine higher than 3 x ULN, or subjects undergoing dialysis.
- •12.Have Diabetes.
- •13.Acute bacterial, fungal or viral infection.
- •14.Have New York Heart Association Class III or IV heart failure
研究者
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