Assess the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Meropenem-Pralubactam (Meropenem/FL058) in China Healthy Adult Participants

NCT07124468 | Recruiting Phase 1

• 1 other identifier: FL058-Ⅰ-05
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Infections

Outcome Measures

Primary Outcomes (1)

• CPlasma、CELF、CAM

  Assessment of plasma, ELF and AM concentrations of Intravenous Meropenem-Pralubactam after 4 doses of Meropenem-Pralubactam

  5 days

Study Arms (1)

Intravenous Meropenem-Pralubactam

EXPERIMENTAL

Drug: Meropenem-Pralubactam

Interventions

Meropenem-Pralubactam DRUG

The study is designed to enroll approximately 16 healthy participants. The study will evaluate the plasma, epithelial lining fluid, and alveolar macrophage concentrations of Meropenem-Pralubactam

Intravenous Meropenem-Pralubactam

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, aged 18-45 years
• Body mass index (BMI): 19-28 kg/m² , with body weight ≥50 kg.
• Pulmonary function at screening:
• 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 with no clinical significance.
• Participant capability:
• 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.
• Reproductive planning:
• No pregnancy, sperm/egg donation plans from signing informed consent through 28 days after last dose
• Participant and partner must use protocol-approved contraception.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, China

RECRUITING

MeSH Terms

Conditions

Infections

Central Study Contacts

Pinfang Huang, bachelor

CONTACT

0591- 87981331; 2363869908@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 15, 2025
• Study Start: September 13, 2025
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-08

Locations

CN (1)