China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced that the first patient has been dosed in a Phase I clinical study for its Category 1 drug candidate GST-HG171. The randomized, double-blind, placebo-controlled study is designed to assess the safety, tolerability, and pharmacokinetics of the drug in healthy Chinese adults through single and multiple escalating doses.
GST-HG171: Drug Profile and Development
GST-HG171 is a 3CL protease (3CLpro) inhibitor with broad-spectrum anti-COVID-19 activities. The drug has demonstrated high-efficiency virus inhibitory activities against the original SARS-CoV-2 virus and Omicron BA.4 and BA.5 variants, as well as beta and delta variants. This broad-spectrum activity positions GST-HG171 as a potential treatment option for multiple COVID-19 variants.
Clinical Study Design
The Phase I study aims to evaluate the safety, tolerability, and pharmacokinetics of GST-HG171 in healthy Chinese adults. The study employs a single and multiple escalating dose design to comprehensively assess the drug’s profile. This initial clinical trial is a crucial step in advancing the development of GST-HG171 as a potential treatment for COVID-19.
Future Outlook
The initiation of the Phase I clinical study for GST-HG171 underscores Fujian Cosunter Pharmaceutical’s commitment to developing innovative treatments for COVID-19. By targeting multiple variants of the virus, GST-HG171 aims to address the evolving nature of the pandemic and provide a much-needed therapeutic option.-Fineline Info & Tech