Qilu Pharmaceutical Initiates Phase I Clinical Trial of Meropenem-Vaborbactam for Anti-Infective Indication

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that Qilu Pharmaceutical Co., Ltd.'s Phase I clinical study evaluating the bronchopulmonary epithelial lining fluid drug concentration and permeability of Meropenem-Plebactam for injection in healthy adult participants in China has been initiated. The clinical trial registration number is CTR20253255, with the initial information disclosure date on August 14, 2025.

The drug formulation is an injectable, with a dosage of 3.0g administered intravenously every 8 hours for a total of 4 doses. The purpose of this trial is to evaluate the drug concentration and permeability in bronchoalveolar epithelial lining fluid (ELF) and alveolar macrophages (AM) in healthy adult participants in China after intravenous infusion of Meropenem-Plazbactam.

Meropenem Plebactam for Injection is a chemical drug, with the indication for anti-infection. Infection refers to the invasion of pathogens into the human body, triggering inflammatory responses, with symptoms such as fever and pain. Diagnosis relies on symptoms, signs, and laboratory tests. Treatment requires the use of appropriate anti-infective drugs.

The primary endpoint indicators of this trial include the concentrations of Meropenem and Plazbacitan in plasma, ELF, and AM at each time point (CPlasma, CELF, CAM). The secondary endpoint indicators include the area under the drug concentration-time curve in plasma for Meropenem and Plazbacitan (AUCPlasma0 - 8h, AUCPlasma0 - 12h, AUCPlasma0 - ∞), adverse events, vital signs, physical examinations, 12-lead electrocardiogram, thin-section computed tomography of the chest (TSCT), and laboratory tests, etc.

Currently, the experiment status is ongoing (not yet recruiting), with a target enrollment of 16 participants.

Risk Warning: The market involves risks, and investments should be made with caution. This article is automatically published by an AI model based on a third-party database. Any information appearing in this article (including but not limited to individual stocks, comments, forecasts, charts, indicators, theories, or any form of expression, etc.) is for reference only and does not constitute personal investment advice. Due to issues such as the quality of the third-party database, we are unable to verify or confirm the authenticity and completeness of the data. Therefore, the content of this article may contain inaccuracies, incompleteness, or misleading information. Please refer to official company announcements for specific details. If you have any questions, please contact biz@staff.sina.com.cn.

Editor: Xiaolang Express