Phase 1, Single-center, Open-label, Randomized, Crossover Design Clinical Trial in Healthy Normal Volunteers to Evaluate Insulin Exposure and Dose-proportionality Following Inhalation of Technosphere® Insulin Inhalation Powder (3 U and 4 U Insulin/mg) Using the Gen2 Inhaler
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The relative exposure (Cmax and AUC0-120) of insulin from TI Inhalation Powder as delivered
研究概览
简要总结
Phase 1 clinical trial to evaluate insulin exposure using different formulations of Technosphere Insulin Inhalation Powder using the Gen2 inhaler in healthy normal volunteers.
详细描述
Phase 1, single-center, open-label, randomized, crossover clinical trial to evaluate insulin exposure using the 3 U/mg and 4 U/mg Technosphere Insulin Inhalation Powder formulations administered using the Gen2 inhaler in 31 healthy volunteers. Drop outs will be replaced. Each subject will undergo a screening visit and either 4 or 5 days of in clinic stay and dosing, depending on randomization schedule.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smoking (within the last 6 months) men and women aged 18 to 45 years who are considered healthy
- •Body mass index (BMI) < 32 kg/m2
- •FEV1 ≥ 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted
排除标准
- •Pre-existing asthma or chronic obstructive pulmonary disease (COPD)
- •History of coronary artery disease, peripheral vascular disease, or congestive heart failure
- •Blood donation within the previous 3 months
研究组 & 干预措施
Cohort 1
干预措施: Technosphere® Insulin Inhalation Powder (Drug)
Cohort 2
干预措施: Technosphere® Insulin Inhalation Powder (Drug)
结局指标
主要结局
The relative exposure (Cmax and AUC0-120) of insulin from TI Inhalation Powder as delivered
时间窗: 0-120 minutes
次要结局
- Safety will be assessed by adverse events(32 days)
- Safety will be assessed by Spirometry (FEV1)(32 Days)
- Safety will be assessed by vital sign measurements(32 Days)
- Safety will be assessed by clinical laboratory test results.(32 Days)
- Safety will be assessed by physical examination findings.(32 Days)