Phase III clinical trial of injection MRX-4 for complex skin and soft tissue infections in China officially launched
Time:2023-09-01 / View:332 times
Recently, Shanghai MicuRx Pharmaceutical Co., Ltd. announced the official launch of its independently developed anti Gram positive bacteria injection MRX-4 phase III clinical trial in China for cSSTI (complex skin and soft tissue infections). The Antibiotics Research Institute of Huashan Hospital affiliated to Fudan University, as the leader unit of this study, enrolled the first subject, This is also the sixth subject enrolled in this clinical trial.
The trial of MRX-4 for injection against cSSTI is a multi-center, randomized, double-blind and double simulation phase III clinical trial, which mainly evaluates the safety and effectiveness of MRX-4 for injection in the treatment of cSSTI, and helps MRX-4 for injection to be approved and marketed in Chinese Mainland. MRX-4 for injection can be converted into the active ingredient contezolid in the human body, greatly expanding the usage scenarios. After being launched, it can provide more medication convenience for critically ill patients and patients who are not suitable for oral administration.
It is worth noting that the Phase III clinical trial was led by Professor Zhang Yingyuan and Professor Huang Haihui from Huashan Hospital affiliated to Fudan University. Professor Zhang Yingyuan is a lifelong professor and former director of the Antibiotics Research Institute at Huashan Hospital affiliated to Fudan University. Since the 1980s, she has been committed to the clinical treatment and research of antibiotics, bacterial resistance, and infectious diseases. Professor Huang Haihui is the deputy director of the Antibiotics Research Institute of Huashan Hospital affiliated to Fudan University. He has long been engaged in the diagnosis and treatment of infectious diseases such as bacteria and fungi in the clinical front line, and has rich clinical experience.
In addition to the Clinical Research Center of Huashan Hospital, other clinical centers of the project are also organizing patient enrollment in an orderly manner. It is expected that approximately 50 research centers nationwide will participate in this clinical trial, with no less than 300 patients planned to be enrolled. As of the time of publication, about one-third of the research centers for the project have been successfully launched, with Zhang Shifa’s team from Northeast International Hospital completing the first enrollment of the project. Other centers are also continuously screening qualified subjects for the project. Each center will strictly adhere to ethical and GCP treaties, maintain high standards, and ensure the high-quality completion of clinical trials for MRX-4.