NCT01355016已完成1 期
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled MDT-637 in Healthy Volunteers
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
- 48
- 试验地点
- 1
- 主要终点
- Safety and Tolerability of 6 escalating doses of MDT-637 dry powder inhalation in healthy volunteers
研究概览
简要总结
The purpose of this study is to determine the range of single inhaled doses of a new dry powder product, MDT-637, that are safe and well-tolerated. This includes monitoring effects on pulmonary function and determination of blood levels of MDT-637 following inhalation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Males and/or surgically sterile or post-menopausal females (confirmed by FSH test); males must agree to practice barrier contraception 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 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 and 24 hours after dosing
排除标准
- •Uncontrolled, clinically significant disease which in the opinion of the Principal Investigator and MDT would place the subject at risk through study participation or would confound the assessment of the safety of MDT-637
- •Evidence of current or history of respiratory disease, including asthma, emphysema, chronic bronchitis, or cystic fibrosis
- •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 within 14 days of Visit 2 or over-the-counter preparations, including dietary and herbal supplements, within 5 days of Visit 2
- •Positive serum pregnancy test at Visit 1
- •Inability to perform reproducible spirometry
- •Abnormal FEV1, FVC, or FEV1/FVC (FEV1and FVC < 85% of predicted and variability of <5% or FEV1/FVC ratio < 0.7)
- •Abnormal QTc interval at Visit 1(>450 msec in males or > 470 msec in females)
- •Significant blood donation (or testing) in previous 8 weeks
研究组 & 干预措施
MDT-637
Experimental
Active formulation
干预措施: MDT-637 (Drug)
Placebo
Placebo Comparator
Matched Placebo Comparator
干预措施: MDT-637 (Drug)
结局指标
主要结局
Safety and Tolerability of 6 escalating doses of MDT-637 dry powder inhalation in healthy volunteers
时间窗: Up to 22 days (including 14 day 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(24 hours)
- Trough MDT-637 Nasal Concentration(24 hours)
- Plasma pharmacokinetics of MDT-637 dry powder inhalation(24 hours)
研究者
研究点 (1)
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