Assess the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Meropenem-Pralubactam (Meropenem/FL058) in China Healthy Adult Participants
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
Qilu Pharmaceutical Co., Ltd.
16 participants
Sep 13, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria14
- 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 Criteria14
- 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.
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Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07124468