August 4, 2021 The Phase I Clinical Study Paper on Our Company’s Class 1 Innovative Drug, “Recombinant Human Thymosin β4 for Injection” (Code Name: NL005) “A first-in-human, randomized, double-blind, single- and multiple-dose, phase I study of recombinant human thymosin β4 in healthy Chinese volunteers” Officially published in the Journal of Cellular and Molecular Medicine.

The Phase I clinical study includes human tolerability trials, pharmacokinetics (PK), and immunogenicity (ADA). Specifically, the single-dose trial randomly enrolled 54 subjects, divided into 7 dose groups; the multiple-dose trial randomly enrolled 30 subjects, divided into 3 dose groups. The observation period for both trials was 28 days.

The trial results indicate that NL005 exhibits high safety and good tolerability in humans, with no serious adverse reactions associated with NL005 observed. Moreover, the pharmacokinetic properties of NL005 meet the requirements for the development of human therapeutic drugs, and no immunogenicity was detected. These findings support the continued clinical investigation of NL005 for the treatment of reperfusion injury in acute myocardial infarction and provide a reliable scientific basis for designing subsequent clinical study protocols.

Link to the original paper  ：

         https://doi.org/10.1111/jcmm.16693