NCT01556607已完成1 期
A Double-Blind, Randomized, 3 Period Crossover, Single Ascending Dose Study to Assess the Safety, and Tolerability of Inhaled MDT-637 in Subjects With Intermittent, or Mild-to-Moderate Persistent, Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety and Tolerability of escalating doses of MDT-637 when inhaled by subjects with Intermittent, or Mild-to-Moderate Persistent, Asthma.
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of MDT-637, when inhaled by subjects with Intermittent, or Mild-to-Moderate Persistent, Asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented clinical history and physician diagnosis of intermittent or mild or moderate persistent asthma for at least 6 months prior to screening OR subjects with historical record of Beta-agonist reversibility within previous 5 years
- •Subjects must demonstrate bronchial hyper-reactivity on methacholine challenge of PC20 less than 8mg/mL.
- •Visit 2 FEV1 (with no treatment change in the interim) must be within 12% of Visit 1 result
- •Males and/or females (if not surgically sterile or confirmed to be post menopausal) must agree to practice 2 barrier contraception methods until they are discharged from the study
- •Willing to give written informed consent
- •18 to 50 years of age
- •BMI of 19-30 kg/m2
- •Non-smoker (for at least 90 days prior to screening) and willing to abstain from smoking during the course of the study
- •Good general health (excepting asthma) as determined by medical history, physical examination, ECG and clinical laboratory tests
- •Willing to abstain from alcohol, caffeine, and xanthine-containing beverages for 24 hours prior to dosing and for 24 hours after dosing.
排除标准
- •Uncontrolled, clinically significant disease which in the opinion of the Principal Investigator, Medical Monitor or Sponsor (MicroDose Therapeutx; MDTx) would place the subject at risk through study participation or would confound the assessment of the safety of MDT-637
- •Inability to perform acceptable and repeatable spirometry in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines
- •Abnormal FEV1, FVC, or FEV1/FVC (FEV1 and FVC < 75% of predicted and/or FEV1/FVC ratio < 0.7)
- •FEV1 variability > 12% between Visit 1 and Visit 2
- •Evidence of current or history of additional respiratory disease (other than asthma); for instance emphysema, chronic bronchitis or cystic fibrosis.
- •Upper respiratory tract infection within 6 weeks of Visit 1
- •Use of rescue albuterol or other short acting bronchodilator (SAB) more often than five times per week
- •History of significant nasal irritation from nasal inhalation of medication
- •History of malignancy
- •History of clinically significant alcohol or drug abuse
- •Positive drug screen for drugs of abuse
- •Positive test for HIV, Hepatitis B or Hepatitis C
- •Allergy to lactose, or lactose intolerance
- •Use of prescription medication (other than SAB and/or low dose inhaled corticosteroid e.g. fluticasone propionate 44 mcg BID or budesonide 100 mcg BID or equivalent) within 14 days of Visit 2 or over-the-counter preparations, including dietary and herbal supplements, within 5 days of Visit 2
- •Positive urine pregnancy test at Visit 1 or Visit 2 or visit 4
- •Abnormal QTc interval at Visit 1(> 450 msec in males or > 470 msec in females)
- •Significant blood donation (or testing) in previous 8 weeks
- •Use of any Investigational Product in previous 6 weeks (small molecule products) or previous 3 months (biologic products)
研究组 & 干预措施
Experimental: MDT-637
Active Comparator
干预措施: MDT-637 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability of escalating doses of MDT-637 when inhaled by subjects with Intermittent, or Mild-to-Moderate Persistent, Asthma.
时间窗: Up to 61 days (including up to 42 days of screening period)
Safety measurements include Clinical Laboratory Evaluations, Pulmonary Function Tests (Spirometry), ECG, Vital Signs, Physical Examination and Assessment of Adverse Events.
次要结局
- Plasma pharmacokinetics for MDT-637 dry powder inhalation(Multiple plasma samples collected, upto 24 hr post last dose)
研究者
研究点 (1)
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