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Safety, tolerability, and pharmacokinetics of VV116, an oral nucleoside analog against SARS-CoV-2, in Chinese healthy subjects.
Qian, Hong-Jie; Wang, Yu; Zhang, Meng-Qi; Xie, Yuan-Chao; Wu, Qing-Qing; Liang, Li-Yu; Cao, Ye; Duan, Hua-Qing; Tian, Guang-Hui; Ma, Juan; Zhang, Zhuo-Bing; Li, Ning; Jia, Jing-Ying; Zhang, Jing; Aisa, Haji Akber; Shen, Jing-Shan; Yu, Chen; Jiang, Hua-Liang; Zhang, Wen-Hong; Wang, Zhen; Liu, Gang-Yi.
  • Qian HJ; Central Laboratory, Shanghai Xuhui Central Hospital/Xuhui Hospital, Fudan University, Shanghai, 200031, China.
  • Wang Y; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, 200031, China.
  • Zhang MQ; CAS Key Laboratory of Receptor Research, Drug Discovery and Design Center, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 201203, China.
  • Xie YC; Central Laboratory, Shanghai Xuhui Central Hospital/Xuhui Hospital, Fudan University, Shanghai, 200031, China.
  • Wu QQ; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, 200031, China.
  • Liang LY; CAS Key Laboratory of Receptor Research, Drug Discovery and Design Center, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 201203, China.
  • Cao Y; Lingang Laboratory, Shanghai, 201602, China.
  • Duan HQ; Central Laboratory, Shanghai Xuhui Central Hospital/Xuhui Hospital, Fudan University, Shanghai, 200031, China.
  • Tian GH; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, 200031, China.
  • Ma J; Central Laboratory, Shanghai Xuhui Central Hospital/Xuhui Hospital, Fudan University, Shanghai, 200031, China.
  • Zhang ZB; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, 200031, China.
  • Li N; Central Laboratory, Shanghai Xuhui Central Hospital/Xuhui Hospital, Fudan University, Shanghai, 200031, China.
  • Jia JY; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, 200031, China.
  • Zhang J; Clinical Department, Vigonvita Life Sciences Co., Ltd, Suzhou, 215123, China.
  • Aisa HA; Clinical Department, Vigonvita Life Sciences Co., Ltd, Suzhou, 215123, China.
  • Shen JS; Research and Development Department, Shanghai Junshi Biosciences Co., Ltd, Shanghai, 200126, China.
  • Yu C; Research and Development Department, Shanghai Junshi Biosciences Co., Ltd, Shanghai, 200126, China.
  • Jiang HL; Research and Development Department, Shanghai Junshi Biosciences Co., Ltd, Shanghai, 200126, China.
  • Zhang WH; Central Laboratory, Shanghai Xuhui Central Hospital/Xuhui Hospital, Fudan University, Shanghai, 200031, China.
  • Wang Z; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, 200031, China.
  • Liu GY; Phase 1 Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, 200040, China.
Acta Pharmacol Sin ; 43(12): 3130-3138, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-1747246
ABSTRACT
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 Cmax increased in an approximately dose-proportional manner in the dose range of 25-800 mg. T1/2 was within 4.80-6.95 h. In MAD, the accumulation ratio for Cmax and AUC indicated a slight accumulation upon repeated dosing of VV116. In FE, the standard meal had no effect on Cmax 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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / Nucleosides Type of study: Experimental Studies / Randomized controlled trials Limits: Humans Country/Region as subject: Asia Language: English Journal: Acta Pharmacol Sin Journal subject: Pharmacology Year: 2022 Document Type: Article Affiliation country: S41401-022-00895-6

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / Nucleosides Type of study: Experimental Studies / Randomized controlled trials Limits: Humans Country/Region as subject: Asia Language: English Journal: Acta Pharmacol Sin Journal subject: Pharmacology Year: 2022 Document Type: Article Affiliation country: S41401-022-00895-6