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NCT Number: NCT07124468

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

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

Recruiting

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, China

Location status: Recruiting

Location contact

Pinfang Huang, bachelor

CONTACT

[email protected]

0591- 87981331

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. CPlasma、CELF、CAM

    Time frame: 5 days

    Assessment of plasma, ELF and AM concentrations of Intravenous Meropenem-Pralubactam after 4 doses of Meropenem-Pralubactam

Study contacts

Contact information is provided by the study sponsor or research team.

Pinfang Huang, bachelor

CONTACT

[email protected]

0591- 87981331

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 15, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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