Assess the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Meropenem-Pralubactam (Meropenem/FL058) in China Healthy Adult Participants
Trial Parameters
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * Male or female, aged 18-45 years * Body mass index (BMI): 19-28 kg/m² , with body weight ≥50 kg. * Pulmonary function at screening: 1. Forced expiratory volume in 1 second (FEV₁) measured/predicted \>80% 2. Forced vital capacity (FVC) measured/predicted \>80% 3. All other ventilation and diffusion parameters normal or with no clinical significance. * Participant capability: 1. Ability to communicate effectively with investigators 2. Willingness to comply with study procedures 3. Voluntary participation with acceptance of bronchoalveolar lavage (BAL) 4. Provision of written informed consent. * Reproductive planning: 1. No pregnancy, sperm/egg donation plans from signing informed consent through 28 days after last dose 2. Participant and partner must use protocol-approved contraception. Exclusion Criteria: * Hypersensitivity to cephalosporins or carbapenem antibiotics. * History or current diagnosis of respiratory system diseases. * History or current diagnosis of c