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The Safety and Efficacy of Multiple-dose of JS002 in Subject With Hyperlipidemia

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研究单位: [1]Shanghai Junshi Bioscience Co., Ltd. [2]The First Affiliated Hospital of Bengbu Medical College,Bengbu,Anhui,China,233000 [3]Beijing Anzhen Hospital, Capital Medical University,Beijing,Beijing,China,100000 [4]Beijing Chaoyang Hospital, Capital Medical University,Beijing,Beijing,China,100000 [5]Beijing Tongren Hospital Affiliated to Capital Medical University City:Beijing,Beijing,Beijing,China,100000 [6]China-Japan Friendship Hospital,Beijing,Beijing,China,100000 [7]Peking University Third Hospital,Beijing,Beijing,China,100000 [8]The Second Affiliated Hospital of Chongqing Medical University,Chongqing,Chongqing,China,400000 [9]The 900 Hospital of the Joint Service Support Force of the People''s Liberation Army of China,Fuzhou,Fujian,China,350000 [10]The First Affiliated Hospital of Fujian Medical University,Fuzhou,Fujian,China,350000 [11]Lanzhou University Second Hospital,Lanzhou,Gansu,China,730000 [12]The First Hospital of Lanzhou University City:Lanzhou,Lanzhou,Gansu,China,730000 [13]Sun Yat-sen Memorial Hospital, Sun Yat-sen University,Guangzhou,Guangdong,China,5100000 [14]Guangdong General Hospital,Guangzhou,Guangdong,China,510000 [15]The First Affiliated Hospital, Sun Yat-sen University,Guangzhou,Guangdong,China,510000 [16]Peking University Shenzhen Hospital,Shenzhen,Guangdong,China,518000 [17]The People''s Hospital of Guangxi Zhuang Autonomous Region,Nanning,Guangxi,China,530000 [18]Affiliated Hospital of Guizhou Medical University,Guiyang,Guizhou,China,550000 [19]Hainan General Hospital,Haikou,Hainan,China,570100 [20]The First Hospital of Hebei Medical University,Shijiazhuang,Hebei,China,050000 [21]The Second Hospital of Hebei Medical University,Shijiazhuang,Hebei,China,050000 [22]Daqingshi People''s Hospital,Daqing,Heilongjiang,China,163316 [23]The Fourth Affiliated Hospital of Harbin Medical University,Haerbin,Heilongjiang,China,15000 [24]The First Affiliated Hospital of Henan University of Science and Technology,Luoyang,Henan,China,471000 [25]The First Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan,China,450000 [26]Jingzhou Central Hospital,Jingzhou,Hubei,China,434000 [27]Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology,Wuhan,Hubei,China,430000 [28]The Third Xiangya Hospital of Central South University,Changsha,Hunan,China,410000 [29]The Second Xiangya Hospital of Central South University,Changsha,Hunan,China,410100 [30]The Second People''s Hospital of Changzhou,Changzhou,Jiangsu,China,213000 [31]Zhongda Hospital Southeast Universty,Nanjing,Jiangsu,China,210009 [32]Affiliated Hospital of Xuzhou Medical University,Xuzhou,Jiangsu,China,221000 [33]Northern Jiangsu People''s Hospital,Yangzhou,Jiangsu,China,225000 [34]The First Hospital of Nanchang,Nanchang,Jiangxi,China,330000 [35]The Second Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China,330000 [36]First Hospital of Jilin University,Changchun,Jilin,China,130000 [37]China-Japan Union Hospital of Jilin University,Changchun,Jilin,China,130033 [38]The central hospital of Dalian,Dalian,Liaoning,China,116000 [39]The First Affiliated Hospital of Jinzhou Medical University,Jinzhou,Liaoning,China,121000 [40]The People''s Hospital of Liaoning Provincial,Shenyang,Liaoning,China,110000 [41]General Hospital of the PLA Northern Theater Command,Shenyang,Liaoning,China,110020 [42]Jinan Central Hospital,Jinan,Shandong,China,250000 [43]Qilu Hospital of Shandong University,Jinan,Shandong,China,250000 [44]Huashan Hospital Affiliated to Fudan University,Shanghai,Shanghai,China,200000 [45]Ruijin Hospital, Shanghai Jiao Tong University School of Medicine,Shanghai,Shanghai,China,200000 [46]Shanghai Changhai Hospital,Shanghai,Shanghai,China,200000 [47]Shanghai East Hospital,Shanghai,Shanghai,China,200000 [48]First Hospital of Shanxi Medical University,Taiyuan,Shanxi,China,030000 [49]Shanxi Provincial People''s Hospital,Taiyuan,Shanxi,China,030000 [50]Xianyang Hospital of Yan ''an University,Xianyang,Shanxi,China,712000 [51]The First Affiliated Hospi

研究目的:
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy, as well as immunogenicity of JS002 treated repeatedly in patients with hyperlipidemia when combined with statin therapy. In this study, two dose group (150 mg, 300 mg) were set up in this study. 750 subjects are plan to be enrolled (the study drug will be assigned to a 2:1 ratio of JS002 or placebo). Each subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks of follow-up.

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