Clinical Trial

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

Recruiting Phase 1
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Record status
This record was last updated September 22, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-08.
Status change: Not Yet Recruiting → Recruiting 2025-09-18
Trial Details
NCT Number NCT07124468
Lead Sponsor Qilu Pharmaceutical Co., Ltd.
Conditions Infections
Enrollment 16 participants
Start Date 2025-09-13
Primary Completion 2025-12 (estimated)
Study Completion 2026-02 (estimated)
Updated on ClinicalTrials.gov 2025-09-22