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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Pinfang Huang, bachelor
• Email: 2363869908@qq.com
• Phone: 0591- 87981331

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.