典型文献
Safety,tolerability,and pharmacokinetics of VV116,an oral nucleoside analog against SARS-CoV-2,in Chinese healthy subjects
文献摘要：
W116(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 W116 in healthy subjects,as well as the effect of food on the pharmacokinetics and safety of W116,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.W116 tablets or placebo were administered per protocol requirements.Blood samples were collected at the scheduled time points for pharmacokinetlc analysis.116-N1,the metabolite of W116,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 W116.In FE,the standard meal had no effect on Cmax and AUC of W116.No serious adverse event occurred in the studies,and no subject withdrew from the studies due to adverse events.Thus,W116 exhibited satisfactory safety and tolerability in healthy subjects,which supports the continued investigation of W116 in patients with COVID-19.
文献关键词：
中图分类号：
作者姓名：
Hong-jie Qian;Yu Wang;Meng-qi Zhang;Yuan-chao Xie;Qing-qing Wu;Li-yu Liang;Ye Cao;Hua-qing Duan;Guang-hui Tian;Juan Ma;Zhuo-bing Zhang;Ning Li;Jing-ying Jia;Jing Zhang;Haji Akber Aisa;Jing-shan Shen;Chen Yu;Hua-liang Jiang;Wen-hong Zhang;Zhen Wang;Gang-yi Liu
作者机构：
Central Laboratory,Shanghai Xuhui Central Hospital/Xuhui Hospital,Fudan University,Shanghai 200031,China;Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs,Shanghai 200031,China;CAS Key Laboratory of Receptor Research,Drug Discovery and Design Center,Shanghai Institute of Materia Medica,Chinese Academy of Sciences,Shanghai 201203,China;Lingang Laboratory,Shanghai 201602,China;Clinical Department,Vigonvita Life Sciences Co.,Ltd,Suzhou 215123,China;Research and Development Department,Shanghai Junshi Biosciences Co.,Ltd,Shanghai 200126,China;Phase 1 Clinical Research Center,Huashan Hospital,Fudan University,Shanghai 200040,China;State Key Laboratory Basis of Xinjiang Indigenous Medicinal Plants Resource Utilization,Xinjiang Technical Institute of Physics and Chemistry,Chinese Academy of Sciences,Urumqi 830011,China;State Key Laboratory of Drug Research,Shanghai Institute of Materia Medica,Chinese Academy of Sciences,Shanghai 201203,China;Department of Infectious Diseases,Huashan Hospital,Fudan University,Shanghai 200040,China
文献出处：
引用格式：
[1]Hong-jie Qian;Yu Wang;Meng-qi Zhang;Yuan-chao Xie;Qing-qing Wu;Li-yu Liang;Ye Cao;Hua-qing Duan;Guang-hui Tian;Juan Ma;Zhuo-bing Zhang;Ning Li;Jing-ying Jia;Jing Zhang;Haji Akber Aisa;Jing-shan Shen;Chen Yu;Hua-liang Jiang;Wen-hong Zhang;Zhen Wang;Gang-yi Liu-.Safety,tolerability,and pharmacokinetics of VV116,an oral nucleoside analog against SARS-CoV-2,in Chinese healthy subjects)[J].中国药理学报（英文版）,2022(12):3130-3138
A类：
W116,JT001,pharmacokinetlc
B类：
Safety,tolerability,pharmacokinetics,VV116,oral,nucleoside,analog,against,SARS,CoV,Chinese,healthy,subjects,drug,candidate,purpose,three,phase,studies,was,evaluate,safety,single,multiple,ascending,doses,well,effect,food,Three,were,launched,sequentially,Study,study,SAD,MAD,FE,total,enrolled,tablets,placebo,administered,per,protocol,requirements,Blood,samples,collected,scheduled,points,analysis,N1,metabolite,detected,plasma,calculated,PK,parameters,Cmax,Increased,approximately,proportional,manner,range,within,accumulation,ratio,indicated,slight,upon,repeated,dosing,standard,meal,had,no,No,serious,adverse,occurred,withdrew,from,due,events,Thus,exhibited,satisfactory,which,supports,continued,investigation,patients
AB值：
0.46027
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