Phase I, Reference-controlled, Dose Escalating Study to Examine the Pharmacokinetics and Safety of AeroVanc Inhalation Powder.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Savara Inc.
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Safety and Tolerability - Number of Participants With Treatment Emergent Adverse Events (TEAEs = Adverse Events That Started During or After the First Dose of Study Drug)
研究概览
简要总结
The study is carried out to evaluate the safety, tolerability and pharmacokinetics of AeroVanc inhalation powder in healthy volunteers, and in patients with cystic fibrosis.
详细描述
The study has three main objectives:
- To evaluate the safety, and tolerability of AeroVanc inhalation powder in healthy volunteers, and in patients with CF.
- To determine the systemic bioavailability of vancomycin in healthy volunteers following single dose pulmonary administration of 16 mg, 32 mg, and 80 mg doses of AeroVanc in comparison with a 250 mg dose of vancomycin administered intravenously.
- To estimate the lung sputum concentrations of vancomycin in patients with cystic fibrosis (CF) following single dose pulmonary administration of 32 mg and 80 mg doses of AeroVanc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Aerovanc 16 mg in healthy volunteers
干预措施: AeroVanc (Drug)
AeroVanc 32 mg in healthy volunteers
干预措施: AeroVanc (Drug)
AeroVanc 80 mg in healthy volunteers
干预措施: AeroVanc (Drug)
IV vancomycin in healthy volunteers
干预措施: IV vancomycin hydrochloride (Drug)
AeroVanc 32 mg in CF patients
干预措施: AeroVanc (Drug)
AeroVanc 80 mg in CF patients
干预措施: AeroVanc (Drug)
结局指标
主要结局
Safety and Tolerability - Number of Participants With Treatment Emergent Adverse Events (TEAEs = Adverse Events That Started During or After the First Dose of Study Drug)
时间窗: Healthy volunteers = 2 weeks; CF Patients = 1 week
Each participant was monitored regularly for Adverse Events (AEs) throughout the study. The Investigator or designee enquired about AEs by asking participants non-leading questions such as: "How do you feel?" or "Have you had any (other) medical problems since your last visit/assessment?" Additionally, several safety procedures (physical examinations, vital signs, safety laboratory tests, 12-lead ECGs, and spirometry) were conducted on participants at regular intervals. All AEs reported spontaneously by participants or in response to questioning or observation by the Investigator, including those related to safety procedures, were recorded. For each AE, the Investigator recorded the following assessments: seriousness, severity (Mild, Moderate, or Severe), and relationship to study drug (Not Related, Remote, Possible, Probable, or Highly Probable). AEs were considered drug-related if given a relationship of Possible, Probable, or Highly Probable.
次要结局
- Plasma Pharmacokinetics - Time to Reach the Maximum Plasma Concentration (Tmax)(Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
- Plasma Pharmacokinetics - Maximum Plasma Concentration (Cmax)(Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
- Plasma Pharmacokinetics - Area Under the Plasma Concentration-time Curve From Time 0 to Infinite Time (AUCinf)(Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
- Lung Pharmacokinetics - Maximum Sputum Concentration (Cmax)(1, 8 and 24 hours post-dose)
- Plasma Pharmacokinetics - Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUCt)(Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
- Plasma Pharmacokinetics - Elimination Half Life (t½)(Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
- Lung Pharmacokinetics - Minimum Sputum Concentration (Cmin)(1, 8 and 24 hours post-dose)