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

文献类型：期刊论文

作者Qian, Hong-jie2,3; Wang, Yu4; Zhang, Meng-qi2,3; Xie, Yuan-chao4,5; Wu, Qing-qing2,3; Liang, Li-yu2,3; Cao, Ye2,3; Duan, Hua-qing6; Tian, Guang-hui6; Ma, Juan7
刊名ACTA PHARMACOLOGICA SINICA
出版日期2022-03-16
页码9
关键词VV116 nucleoside analog SARS-CoV-2 safety pharmacokinetics healthy subjects
ISSN号1671-4083
DOI10.1038/s41401-022-00895-6
通讯作者Zhang, Wen-hong(zhangwenhong@fudan.edu.cn) ; Wang, Zhen(wangzhen@lglab.ac.cn) ; Liu, Gang-yi(gyliu@shxh-centerlab.com)
英文摘要VV116 (JT001) is an oral drug candidate of nucleoside analog against SARS-CoV-2. The purpose of the three phase I studies was to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of VV116 in healthy subjects, as well as the effect of food on the pharmacokinetics and safety of VV116. Three studies were launched sequentially: Study 1 (single ascending-dose study, SAD), Study 2 (multiple ascending-dose study, MAD), and Study 3 (food-effect study, FE). A total of 86 healthy subjects were enrolled in the studies. VV116 tablets or placebo were administered per protocol requirements. Blood samples were collected at the scheduled time points for pharmacokinetic analysis. 116-N1, the metabolite of VV116, was detected in plasma and calculated for the PK parameters. In SAD, AUC and C-max increased in an approximately dose-proportional manner in the dose range of 25-800 mg. T-1/2 was within 4.80-6.95 h. In MAD, the accumulation ratio for C-max and AUC indicated a slight accumulation upon repeated dosing of VV116. In FE, the standard meal had no effect on C-max and AUC of VV116. No serious adverse event occurred in the studies, and no subject withdrew from the studies due to adverse events. Thus, VV116 exhibited satisfactory safety and tolerability in healthy subjects, which supports the continued investigation of VV116 in patients with COVID-19.
资助项目Vigonvita Life Science Co., Ltd ; Shanghai JunTop Biosciences Co., Ltd. ; National Key Research and Development Program of China[2021YFC0865000] ; Shanghai Science and Technology Committee[21S11903100] ; Lingang Laboratory[LG202103-04-04] ; 2020 ANSO Collaborative Research Project[ANSO-CR-SP-2020-03]
WOS研究方向Chemistry ; Pharmacology & Pharmacy
语种英语
WOS记录号WOS:000769837300001
出版者NATURE PUBL GROUP
源URL[http://119.78.100.183/handle/2S10ELR8/300012]  
专题新药研究国家重点实验室
通讯作者Zhang, Wen-hong; Wang, Zhen; Liu, Gang-yi
作者单位1.Chinese Acad Sci, Shanghai Inst Mat Med, State Key Lab Drug Res, Shanghai 201203, Peoples R China
2.Fudan Univ, Xuhui Hosp, Shanghai Xuhui Cent Hosp, Cent Lab, Shanghai 200031, Peoples R China
3.Shanghai Engn Res Ctr Phase 1 Clin Res & Qual Con, Shanghai 200031, Peoples R China
4.Chinese Acad Sci, Drug Discovery & Design Ctr, Shanghai Inst Mat Med, CAS Key Lab Receptor Res, Shanghai 201203, Peoples R China
5.Lingang Lab, Shanghai 201602, Peoples R China
6.Vigonvita Life Sci Co Ltd, Clin Dept, Suzhou 215123, Peoples R China
7.Shanghai Junshi Biosci Co Ltd, Res & Dev Dept, Shanghai 200126, Peoples R China
8.Fudan Univ, Huashan Hosp, Phase Clin Res Ctr 1, Shanghai 200040, Peoples R China
9.Chinese Acad Sci, Xinjiang Tech Inst Phys & Chem, State Key Lab Basis Xinjiang Indigenous Med Plant, Urumqi 830011, Peoples R China
10.Fudan Univ, Huashan Hosp, Dept Infect Dis, Shanghai 200040, Peoples R China
推荐引用方式
GB/T 7714		 Qian, Hong-jie,Wang, Yu,Zhang, Meng-qi,et al. Safety, tolerability, and pharmacokinetics of VV116, an oral nucleoside analog against SARS-CoV-2, in Chinese healthy subjects[J]. ACTA PHARMACOLOGICA SINICA,2022:9.
APA Qian, Hong-jie.,Wang, Yu.,Zhang, Meng-qi.,Xie, Yuan-chao.,Wu, Qing-qing.,...&Liu, Gang-yi.(2022).Safety, tolerability, and pharmacokinetics of VV116, an oral nucleoside analog against SARS-CoV-2, in Chinese healthy subjects.ACTA PHARMACOLOGICA SINICA,9.
MLA Qian, Hong-jie,et al."Safety, tolerability, and pharmacokinetics of VV116, an oral nucleoside analog against SARS-CoV-2, in Chinese healthy subjects".ACTA PHARMACOLOGICA SINICA (2022):9.

入库方式： OAI收割

来源：上海药物研究所

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