Actively Recruiting
Assess the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Meropenem-Pralubactam (Meropenem/FL058) in China Healthy Adult Participants
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2025-09-22
16
Participants Needed
1
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 to 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) measured/predicted >80%
- Forced vital capacity (FVC) measured/predicted >80%
- All other ventilation and diffusion parameters normal or without clinical significance
- 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
- No pregnancy or plans for sperm/egg donation from consent through 28 days after last dose
- Participant and partner must use protocol-approved contraception
You will not qualify if you...
- Allergy to cephalosporins or carbapenem antibiotics
- History or diagnosis of respiratory system diseases
- History or diagnosis of coagulation disorders
- Clinically significant diseases in cardiovascular, endocrine, neurological, digestive, hematological, metabolic, or psychiatric systems interfering with study outcomes
- History of smoking or positive nicotine test at screening
- Prior surgery involving pharynx, trachea/bronchi, or lungs
- Drug abuse history within 1 year prior to screening or positive urine drug screen
- 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 prior to screening
- Blood donation or loss of 400 mL or more or blood transfusion within 3 months prior to screening
- Respiratory infections within 2 weeks prior to screening
- Use of any medication/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 pregnancy test at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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