NCT05999942已完成1 期
A Gamma Scintigraphy Study to Investigate the Lung Deposition of Inhaled Amikacin-Loaded Liposomes in Healthy Male 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
- 6
- 主要终点
- Pulmonary Deposition of Radiolabelled Amikacin-loaded Liposomes Measured as Percentage Retention of Emitted Dose Deposited in the Lungs
研究概览
简要总结
The primary purpose of this study is to determine the intra and extra pulmonary deposition and clearance of inhaled amikacin-loaded liposomes by gamma scintigraphy in healthy male participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participants with a body mass index (BMI) of 20-
- •Participants with negative human immunodeficiency virus (HIV) and Hepatitis B and C results.
- •Participants with no clinically significant findings in 12-lead electrocardiogram (ECG) determined within 14 days of the start of the study.
排除标准
- •Participants who had clinically diagnosed asthma.
- •Participants with a known allergic reaction to amikacin, liposomes or any of the radiolabelling products (i.e. [^99m]Tc, or [^111]In, and [^81m]Kr).
- •Evidence of clinically significant pulmonary, renal, hepatic, cardiovascular or metabolic dysfunction.
- •History of smoking within the past 12 months.
- •History of chronic cough or wheezing within the previous 21 days.
- •Participants who had an upper respiratory illness or infection within the previous 21 days.
- •A history of drug or alcohol abuse.
- •Donation of 450 milliliters (mL) or more blood within the previous 12 weeks.
- •Note: Other inclusion/exclusion criteria may apply.
研究组 & 干预措施
Amikacin Liposome Inhalation
Experimental
Participants will receive a single dose of radiolabelled amikacin loaded liposomes by inhalation on Day 1.
干预措施: Liposomal Amikacin for Inhalation (Drug)
结局指标
主要结局
Pulmonary Deposition of Radiolabelled Amikacin-loaded Liposomes Measured as Percentage Retention of Emitted Dose Deposited in the Lungs
时间窗: Pre-administration and 2 hours post-administration on Day 1
次要结局
- Penetration Index Based on the Ratio of Counts in the Central:Peripheral Lung Regions, Corrected for Regional Lung Volume (sC/P)(Pre-administration and 2 hours post- administration on Day 1)
- Percent Dose Deposited in Oropharyngeal and Stomach Region(At multiple timepoints post-administration up to Day 2)
- Percent Dose Remaining in the Device Including the Mouthpiece(At multiple timepoints post-administration up to Day 2)
- Percent Dose Remaining in the Low Resistance Exhalation Filter(At multiple timepoints post-administration up to Day 2)
研究者
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