Phase 1 Study to Measure Levels of Intravenous Meropenem-Pralubactam in Blood, Lung Lining Fluid, and Lung Immune Cells of Healthy Adults in China

What this Trial Is About

Researchers are evaluating the concentrations and permeability of intravenous Meropenem-Pralubactam MeropenemFL058 in healthy adult participants in China. This Phase 1 trial aims to understand the levels of meropenem and pralubactam in plasma, epithelial lining fluid ELF, and alveolar macrophages AM at different time points. The study is sponsored by Qilu Pharmaceutical Co., Ltd. and focuses on healthy adults aged 18 to 45 years with no significant health issues affecting the lungs or other major systems. The study involves administering intravenous Meropenem-Pralubactam to approximately 16 healthy participants. It will measure drug concentrations in plasma, ELF, and AM over a 5-day period. The trial is open-label and randomized, with no masking or placebo control. Participants must meet strict pulmonary function and health criteria and agree to bronchoalveolar lavage BAL procedures. Participants will undergo screening including pulmonary function tests, physical exams, ECGs, and imaging to confirm eligibility. During the trial, researchers will collect samples and monitor drug levels in different body fluids and cells. Safety will be closely observed, including checking for allergic reactions and other adverse effects. The total participation duration aligns with the 5-day primary outcome measurement period, with follow-up for safety and adherence to study procedures.

Assess the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Meropenem-Pralubactam (Meropenem/FL058) in China Healthy Adult Participants