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

Recruiting Phase 1 Interventional Study
Infections
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 45
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
16 (estimated)
Sponsor
Qilu Pharmaceutical Co., Ltd. · Industry
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About This Trial
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 …
Trial Locations
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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 oth…
Contacts

Pinfang Huang, bachelor

0591- 87981331

2363869908@qq.com

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