On May 17th, the first two subjects are formally enrolled in Phase I clinical study for SK08 in Guangdong Provincial People’s Hospital. The Phase I study aims to demonstrate the safety and tolerability of SK08（Bacteroides fragilis）, which is a single-center, randomized, placebo-controlled, double-blinded study conducted in healthy volunteers. In the next 48 hours, the subjects will take the test drug orally for safety observation.

At the end of last year, SK08 project has passed the ethic review of clinical trials but was suspended before subjects screening and enrollment because of the COVID-19. Once the COVID-19 was under control, the sponsors, hospitals, and CRO actively restarted the project and held a project kick-off meeting on April 28 to quickly advance the trial. SK08 is Category 1 of Therapeutic Biological Products (CFDA) developed by Zhiyi, which is one of the few live bacteria drugs using new strain as well as entering the clinical stage in the world. It is an important milestone for live bacteria drug development in China.

SK08 Phase I Clinical Trial Officially Enrolled