The Phase I clinical trial of recombinant human thymosin β4 for injection has officially commenced.
On July 10, 2017, the kickoff meeting for the Phase I clinical trial of "Recombinant Human Thymosin β4 for Injection," hosted by Beijing Northland Biotechnology Co., Ltd., was successfully held at the Kyoto Xinyuan Hotel in Beijing.
The meeting was chaired by Professor Xinghe Wang from the Phase I Clinical Trial Research Laboratory of Beijing Century Tan Hospital, affiliated with Capital Medical University. All members of his team, as well as hospital leaders and key personnel from the clinical trial institution and the ethics committee, attended the meeting. The organizers also invited nearly 40 participants from collaborating institutions, including epidemiology and health statistics experts from Nanjing Medical University, specialized technical staff from Beijing Zhaoyan New Drug R&D Co., Ltd. responsible for bio-sample testing, medical data management personnel from Jiaxing Taimi Medical, subject recruitment personnel from Jingcheng Yongtai Pharmaceutical Technology Co., Ltd., and CRCs in charge of this trial. Attendees listened carefully to presentations on the project overview, the clinical trial protocol, the ADA/PK methodology, and instructions for using the EDC system. They also offered numerous specific suggestions and approaches regarding the implementation of this clinical trial.
Recombinant human thymosin β4 for injection is a new drug project independently developed by NORTHLAND, which can be used to develop medications for indications such as skin injuries, corneal injuries, dry eye syndrome, and myocardial infarction. Currently, clinical trials have been initiated for the indication of acute myocardial infarction; this drug is classified as a Class 1 biologic new drug.
The convening of this meeting marks the official launch of Phase I clinical trials for the recombinant human thymosin β4 injection project (for acute myocardial infarction). The sponsor and collaborating institutions will fully cooperate with the research unit and, in strict accordance with GCP requirements, strive to successfully complete the Phase I clinical trial with high quality.




