NCT07124468招募中1 期
A Phase 1, Randomized, Open-Label, Trial Evaluating the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Intravenous Meropenem-Pralubactam(Meropenem/FL058) in China Healthy Adult Participants
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- CPlasma、CELF、CAM
研究概览
简要总结
The goal of this clinical trial is to evaluate the Epithelial Lining Fluid concentrations and permeability of Intravenous Meropenem-Pralubactam(Meropenem/FL058) in China Healthy Adult Participants. The main question it aims to answer is:
• [question 1] : What are the concentrations of meropenem and Pralubactam in plasma, epithelial lining fluid (ELF), and alveolar macrophages (AM) at each time point
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Male or female, aged 18-45 years
- •Body mass index (BMI): 19-28 kg/m² , with body weight ≥50 kg.
- •Pulmonary function at screening:
- •Forced expiratory volume in 1 second (FEV₁) measured/predicted >80%
- •Forced vital capacity (FVC) measured/predicted >80%
- •All other ventilation and diffusion parameters normal or with no clinical significance.
- •Participant capability:
- •Ability to communicate effectively with investigators
- •Willingness to comply with study procedures
- •Voluntary participation with acceptance of bronchoalveolar lavage (BAL)
- •Provision of written informed consent.
- •Reproductive planning:
- •No pregnancy, sperm/egg donation plans from signing informed consent through 28 days after last dose
- •Participant and partner must use protocol-approved contraception.
排除标准
- •Hypersensitivity to cephalosporins or carbapenem antibiotics.
- •History or current diagnosis of respiratory system diseases.
- •History or current diagnosis of coagulation disorders.
- •Clinically significant diseases in cardiovascular, endocrine, neurological, digestive, hematological, metabolic, or psychiatric systems judged by the investigator to interfere with study outcomes.
- •History of smoking or positive nicotine test during screening.
- •Prior surgery involving pharynx, trachea/bronchi, or lungs.
- •Drug abuse history within 1 year prior to screening or positive urine drug screen at screening.
- •Alcohol intake >14 units/week on average within 6 months prior to screening.
- •Participation in other clinical trials with investigational drugs/devices within 3 months prior to screening.
- •Blood donation/loss ≥400 mL or blood product transfusion within 3 months prior to screening.
- •Respiratory infections (bacterial/fungal/viral) within 2 weeks prior to screening (e.g., upper/lower respiratory tract infections).
- •Use of any medication/vaccination within 14 days prior to screening or planned vaccination during the study.
- •Clinically significant abnormalities in physical examination, 12-lead ECG, or imaging at screening per investigator's judgment.
- •Pregnancy, lactation, or positive serum pregnancy test at screening.
研究组 & 干预措施
Intravenous Meropenem-Pralubactam
Experimental
干预措施: Meropenem-Pralubactam (Drug)
结局指标
主要结局
CPlasma、CELF、CAM
时间窗: 5 days
Assessment of plasma, ELF and AM concentrations of Intravenous Meropenem-Pralubactam after 4 doses of Meropenem-Pralubactam
次要结局
未报告次要终点
研究者
研究点 (1)
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