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

Not Applicable

Not yet recruiting

• Conditions: Infections
• Interventions: Drug: Meropenem-Pralubactam

• Registration Number: NCT07124468
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-08
• Study First Submitted QC: 2025-08-08
• Last Update Submitted: 2025-08-08
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15
• Study Start: 2025-09-01
• Primary Completion: 2025-12
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

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:

  1. Forced expiratory volume in 1 second (FEV₁) measured/predicted >80%
  2. Forced vital capacity (FVC) measured/predicted >80%
  3. All other ventilation and diffusion parameters normal or with no clinical significance.

• Participant capability:

  1. Ability to communicate effectively with investigators
  2. Willingness to comply with study procedures
  3. Voluntary participation with acceptance of bronchoalveolar lavage (BAL)
  4. Provision of written informed consent.

• Reproductive planning:

  1. No pregnancy, sperm/egg donation plans from signing informed consent through 28 days after last dose
  2. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intravenous Meropenem-Pralubactam	Meropenem-Pralubactam	-

Primary Outcome Measures

Name	Time	Method
CPlasma、CELF、CAM	5 days	Assessment of plasma, ELF and AM concentrations of Intravenous Meropenem-Pralubactam after 4 doses of Meropenem-Pralubactam