NCT07124468 Assess the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Meropenem-Pralubactam (Meropenem/FL058) in China Healthy Adult Participants
| NCT ID | NCT07124468 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Condition | Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2025-09-13 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 16 participants in total. It began in 2025-09-13 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07124468 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07124468 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07124468 currently recruiting?
Yes, NCT07124468 is actively recruiting participants. Contact the research team at 2363869908@qq.com for enrollment information.
Where is the NCT07124468 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT07124468 clinical trial?
NCT07124468 is sponsored by Qilu Pharmaceutical Co., Ltd.. The trial plans to enroll 16 participants.