Actively Recruiting
A Phase 1, Randomized, Open-Label Trial Evaluating Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Intravenous Meropenem-Pralubactam in Healthy Adults in China
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2025-09-22
16
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the concentrations and permeability of intravenous Meropenem-Pralubactam (Meropenem/FL058) in healthy adult participants in China. This Phase 1 trial aims to understand the levels of meropenem and pralubactam in plasma, epithelial lining fluid (ELF), and alveolar macrophages (AM) at different time points. The study is sponsored by Qilu Pharmaceutical Co., Ltd. and focuses on healthy adults aged 18 to 45 years with no significant health issues affecting the lungs or other major systems. The study involves administering intravenous Meropenem-Pralubactam to approximately 16 healthy participants. It will measure drug concentrations in plasma, ELF, and AM over a 5-day period. The trial is open-label and randomized, with no masking or placebo control. Participants must meet strict pulmonary function and health criteria and agree to bronchoalveolar lavage (BAL) procedures. Participants will undergo screening including pulmonary function tests, physical exams, ECGs, and imaging to confirm eligibility. During the trial, researchers will collect samples and monitor drug levels in different body fluids and cells. Safety will be closely observed, including checking for allergic reactions and other adverse effects. The total participation duration aligns with the 5-day primary outcome measurement period, with follow-up for safety and adherence to study procedures.
CONDITIONS
Brief Title
Assess the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Meropenem-Pralubactam (Meropenem/FL058) in China Healthy Adult Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 18-45 years
- Body mass index (BMI) between 19 and 28 kg/m² with body weight at least 50 kg
- Pulmonary function with forced expiratory volume in 1 second (FEV1) over 80% of predicted
- Forced vital capacity (FVC) over 80% of predicted
- All other ventilation and diffusion parameters normal or without clinical significance
- Ability to communicate with investigators and comply with study procedures
- Willing voluntary participation including acceptance of bronchoalveolar lavage (BAL)
- Provision of written informed consent
- No pregnancy or sperm/egg donation plans during study and 28 days after last dose
- Use of protocol-approved contraception by participant and partner
You will not qualify if you...
- 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
- History of smoking or positive nicotine test during screening
- Prior surgery involving pharynx, trachea/bronchi, or lungs
- Drug abuse within 1 year or positive urine drug screen at screening
- Alcohol intake over 14 units/week on average within 6 months prior to screening
- Participation in other clinical trials with investigational drugs/devices within 3 months
- Blood donation or loss of 400 mL or more within 3 months prior to screening
- Respiratory infections within 2 weeks prior to screening
- Use of any medication or vaccination within 14 days prior to screening or planned vaccination during study
- Clinically significant abnormalities in physical exam, ECG, or imaging at screening
- Pregnancy, lactation, or positive serum pregnancy test at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants receive intravenous Meropenem-Pralubactam and undergo evaluations of plasma, epithelial lining fluid, and alveolar macrophage concentrations.
Daily visits for 5 days
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Actively Recruiting
Research Team
P
Pinfang Huang, bachelor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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