Safety, tolerability, and pharmacokinetics of VV116, an oral nucleoside analog against SARS-CoV-2, in Chinese healthy subjects.

"Competing interests HQD and GHT are the employees of Vigonvita Life Science Co., Ltd, the sponsor of the study. JM, ZBZ, and NL are the employees of Shanghai Junshi Biosciences Co., Ltd., the parent company of the co-sponsor Shanghai JunTop Biosciences Co., Ltd. YCX, JSS, and HLJ filed a patent application on antiviral nucleoside analogs. The remaining authors declare no competing interests."

"The studies were sponsored by Vigonvita Life Science Co., Ltd and Shanghai JunTop Biosciences Co., Ltd. This work was partially supported by the National Key Research and Development Program of China (No. 2021YFC0865000), the Lingang Laboratory (No. LG202103-04-04), the 2020 ANSO Collaborative Research Project (No. ANSO-CR-SP-2020-03), Shanghai Science and Technology Committee (No. 21S11903100). The authors sincerely thank the healthy subjects and all the staffs who participated in the clinical studies. The authors thank H. Eric Xu for his contribution to English editing and polishing of the manuscript."

"The studies were accomplished at the Phase I Clinical Research Center of Shanghai Xuhui Central Hospital, Shanghai, China, from November 2021 to January 2022. The studies were conducted in accordance with the Declaration of Helsinki (World Medical Association) and Good Clinical Practice (GCP). The study protocol and informed consent forms were approved by the Ethics Committee of the Shanghai Xuhui Central Hospital. All of the subjects provided written informed consent before any study-related procedure was performed. The studies were registered on ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT05227768, NCT05201690, NCT05221138)."