The discussion meeting on the Phase I clinical trial protocol for Recombinant Human Thymosin β4 for Injection (NL005) was successfully held.
On June 23, 2016, the discussion meeting on the Phase I clinical trial protocol for Recombinant Human Thymosin β4 for Injection (NL005), hosted by Beijing Northland Biotechnology Co., Ltd., was successfully held at the Kyoto Xinyuan Hotel in Beijing.
This proposal discussion meeting has invited 11 leading experts from across the country in the fields of Phase I clinical trials, pharmacology, and statistical analysis, including Professor Wang Xinghe, Director of the Phase I Clinical Trial Research Laboratory at Beijing Century Tan Hospital affiliated with Capital Medical University, along with his team; Professor Wei Minji from the Institute of Clinical Pharmacology at Peking University First Hospital; Professor Zhang Yonghe, Associate Director of Pharmacology at the School of Basic Medicine, Peking University; Professor Yu Hao from the Department of Epidemiology and Health Statistics at Nanjing Medical University; and Dr. Li Kaitong from Beijing Zhaoyan New Drug R&D Co., Ltd., among others.
Chief Physician Wang Jin from Beijing Century Hospital gave a detailed explanation of the design rationale behind the clinical trial protocol. The attending experts engaged in in-depth discussions on various aspects, including the rationality of the protocol design, the selection of dosage ranges, the examination items for the screening and follow-up periods, and the development of indications, and reached a unanimous consensus.
Through this discussion, the sponsor and the research institution will further refine the details of the trial protocol to ensure the quality of the Phase I clinical study of recombinant human thymosin β4 injection.




