Plasma and lung fluid measurements of IV meropenem-pralubactam in healthy Chinese adults

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

This test measures how much meropenem-pralubactam reaches the blood, epithelial lining fluid, and alveolar macrophages in healthy adults in China.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Qilu Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Fuzhou)
• Trial ID: NCT07124468 on ClinicalTrials.gov

What this trial studies

Healthy adults aged 18–45 with BMI 19–28 kg/m² and weight ≥50 kg will receive intravenous meropenem-pralubactam and undergo serial blood draws and bronchoalveolar lavage (BAL) to sample epithelial lining fluid (ELF) and alveolar macrophages (AM) at predefined time points. Drug concentrations in plasma, ELF, and AM will be quantified to define pharmacokinetic penetration into the lung. Participants are screened for normal pulmonary function and excluded if they have respiratory disease or hypersensitivity to beta-lactam antibiotics, with safety monitoring throughout. The trial is sponsored by Qilu Pharmaceutical and conducted at The First Affiliated Hospital of Fujian Medical University in Fuzhou.

Who should consider this trial

Good fit: Ideal candidates are healthy adults 18–45 years old, BMI 19–28 kg/m², weight ≥50 kg, with normal lung function, no respiratory disease, willing to undergo bronchoalveolar lavage, and able to provide informed consent.

Not a fit: People with active respiratory disease, pregnant or planning pregnancy, a history of allergy to cephalosporins or carbapenems, those outside the age/BMI limits, or unwilling to undergo bronchoscopy are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, the results could help clinicians choose dosing that ensures meropenem-pralubactam reaches lung tissues to more effectively treat pulmonary infections.

How similar studies have performed: Previous pharmacokinetic studies of meropenem and other beta-lactam/beta-lactamase inhibitor combinations have successfully measured ELF and alveolar macrophage penetration, so the approach is established though this specific combination and Chinese healthy volunteer population is less studied.

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:

  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.

Where this trial is running

Fuzhou

• The First Affiliated Hospital of Fujian Medical University — Fuzhou, China (Recruiting)

Study contacts

• Study coordinator: Pinfang Huang, bachelor

Conditions Infections