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

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT07124468
Phase
PHASE1
Status
Recruiting
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Conditions

  • Infections

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Meropenem-Pralubactam — DRUG
    The study is designed to enroll approximately 16 healthy participants. The study will evaluate the plasma, epithelial lining fluid, and alveolar macrophage concentrations of Meropenem-Pralubactam

Study Details

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

Key Dates

First listed
Aug 15, 2025
Start date
Sep 13, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Intravenous Meropenem-Pralubactam

Primary Outcome Measure

CPlasma、CELF、CAM [ Time Frame: 5 days ]

Central Contacts

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