On October 12, 2018, the kickoff meeting for the Phase I multiple-dose clinical trial of “Recombinant Human Thymosin β4 for Injection” was officially held at the Conference Center of Beijing Century Tan Hospital, affiliated with Capital Medical University. The protocol for this multiple-dose trial was developed based on the results from the Phase I single-dose trial, with the aim of further evaluating the safety and tolerability of multiple doses, exploring the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT), and simultaneously assessing the pharmacokinetic (PK) characteristics and anti-drug antibody (ADA) indicators associated with multiple dosing.

　　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. Nearly 40 people attended the meeting, including all members of his team involved in the trial, as well as representatives from the clinical trial institution, the ethics committee, and heads of various collaborating units. During the meeting, the sponsor and the research team presented and discussed numerous aspects, such as the results of the single-dose trial, the protocol for the multiple-dose clinical trial, and the detailed operational procedures of the trial, thereby clarifying the implementation methods for this clinical trial and ensuring its smooth execution.

　　The convening of this meeting marks the official launch of the Phase I multiple-dose clinical trial for the “Recombinant Human Thymosin β4 for Injection” project. The sponsor and the research institutions will strictly adhere to GCP guidelines and all applicable regulatory requirements, striving to successfully complete all study procedures with high quality.