Menu
Recruiting NCT07124468

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

Phase I Interventional Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Meropenem-Pralubactam.
Who it may be relevant to
Registry conditions: Infections. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug Meropenem-Pralubactam
    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

Primary outcome measures

  • CPlasma、CELF、CAM [Time frame: 5 days]

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:
  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

China · 1 center
  • The First Affiliated Hospital of Fujian Medical University — Fuzhou

Identifiers

NCT: NCT07124468 · FL058-Ⅰ-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗