NCT02315144终止1 期
A 2-Stage, Single-Dose Study in Healthy Volunteers and COPD Patients With an Open Label Ipratropium Bromide Reference to Evaluate the Efficacy, Pharmacokinetics, and Safety Profile of Inhaled TV48108
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 61
- 试验地点
- 7
- 主要终点
- Baseline adjusted forced expiratory volume in 1 second area under the curve over 12 hours (FEV1 AUC0-12h).
研究概览
简要总结
The primary objective of the study is to characterize the safety profile and duration of bronchodilation of a single dose of inhaled TV48108.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stage 1 (Healthy Volunteers)
- •Male or female 20 to 75 years of age, inclusive, weighing 50 to 80 kg with a body mass index (BMI) of less than 30 kg/m^
- •In good health as determined by medical and psychiatric history, physical examination, electrocardiogram (ECG), serum chemistry, hematology, urinalysis, and serology.
- •Other criteria apply, please contact the investigator for more information
- •Stage 2 (Chronic Obstructive Lung Disease (COPD) patients)
- •Male or female; 40 to 75 years of age, inclusive with a minimum body weight of 40 kg
- •Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack years at the screening visit
- •Diagnosis of COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines.
- •Other criteria apply, please contact the investigator for more information
排除标准
- •Stage 1 (Healthy Volunteers)
- •History or current evidence of a clinically significant or uncontrolled disease
- •Any disorder that may interfere with the absorption, distribution, metabolism or excretion of study drugs.
- •History of severe allergy to milk protein
- •Active smokers or former smokers who quit within 3 months of the first dose of study drug. Former smokers with greater than five-pack years (ie, the equivalent of one pack per day for five years) are also excluded.
- •Other criteria apply, please contact the investigator for more information
- •Stage 2 (Chronic Obstructive Lung Disease (COPD) patients)
- •Recent history of hospitalization due to an exacerbation of airway disease within 3 months
- •Need for increased treatments of COPD within 6 weeks prior to the screening visit
- •History of and/or current diagnosis of asthma
- •Known α1 antitrypsin deficiency, active lung infections (such as tuberculosis or pneumonia), and lung cancer are absolute exclusionary conditions
- •Other criteria apply, please contact the investigator for more information
研究组 & 干预措施
TV48108 - Healthy Volunteers
Experimental
Stage 1 is a randomized, placebo-controlled, double-blind, single-dose study. Healthy subjects will be randomized to receive a single inhaled dose of TV48108 120 µg
干预措施: TV48108 (Drug)
Placebo - Healthy Volunteers
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
TV48108 15 µg COPD
Experimental
Stage 2 consists of a 2-period open-label study with an ipratropium bromide reference to evaluate the single administration of 3 ascending doses of inhaled TV48108 in COPD patients.
干预措施: TV48108 (Drug)
TV48108 60 µg COPD
Experimental
Stage 2
干预措施: TV48108 (Drug)
TV48108 120 µg COPD
Experimental
Stage 2 .
干预措施: TV48108 (Drug)
结局指标
主要结局
Baseline adjusted forced expiratory volume in 1 second area under the curve over 12 hours (FEV1 AUC0-12h).
时间窗: Day 1 (pre-dose, up to 12 hours post-dose)
次要结局
- Baseline Adjusted Trough 12 hour forced expiratory volume in 1 second (FEV1)(Day 1 (pre-dose, up to 12 hours post-dose))
- Percentage of Participants with Adverse Events(28 Days)
研究者
研究点 (7)
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