A Single Center Study to Evaluate the Penetration of RO7033877 Into the Lung in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Multiple-dose pharmacokinetics of RO7033877 for plasma, epithelial lining fluid (ELF), and alveolar macrophage (AM): Cmax and AUC
研究概览
简要总结
This single-center, open-label study will investigate RO7033877 concentrations in plasma and in various lung compartments, including epithelial lining fluid (ELF), and alveolar macrophages (AM) in healthy volunteers after multiple intravenous (IV) administration. Bronchoscopy will be performed after the start of the last infusion on Day 3 at different timepoints. Blood, urine and brochoalveolar lavage samples will be collected to determine RO7033877 concentrations. The anticipated time on study treatment is 3 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female healthy volunteers, 18 to 55 years of age, inclusive. A female participant is eligible to participate if she is of non-childbearing potential defined as postmenopausal or surgically sterile
- •Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology and urinalysis
- •Body mass index (BMI) between 18 and 30 kg/m2 inclusive
- •Nonsmokers
- •Healthy male volunteers with female partners of childbearing potential must use adequate contraception methods
排除标准
- •Evidence of active chronic disease
- •Regular consumption of drugs of abuse
- •Infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV)
- •History of clinically significant hypersensitivity or allergic drug reactions
- •Clinically significant abnormalities (e.g. cardiovascular, laboratory values)
- •Abnormal blood pressure or vital signs
- •Contraindications to bronchoalveolar lavage (BAL)
研究组 & 干预措施
RO7033877
干预措施: RO7033877 + Bronchoscopy (Drug)
结局指标
主要结局
Multiple-dose pharmacokinetics of RO7033877 for plasma, epithelial lining fluid (ELF), and alveolar macrophage (AM): Cmax and AUC
时间窗: 5 days (in-clinic period)
ELF and AM/Plasma Ratios of Cmax and AUC
时间窗: 5 days (in-clinic period)
次要结局
- Incidence of adverse events (AEs)(Up to 12 days)
- Changes in clinical laboratory safety tests, vital signs, and ECGs(Up to 6 weeks)