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Safety and efficacy of meplazumab in healthy volunteers and COVID-19 patients: a randomized phase 1 and an exploratory phase 2 trial

查看全文 作　　者：Huijie [1]Bian;Zhao-Hui [2]Zheng;Ding [1]Wei;Aidong [3]Wen;Zheng [1]Zhang;Jian-Qi [4]Lian;Wen-Zhen [4]Kang;Chun-Qiu [4]Hao;Jing [5]Wang;Rong-Hua [2]Xie;Ke [6]Dong;Jie-Lai [7]Xia;Jin-Lin [1]Miao;Wen [4]Kang;Guoquan [5]Li;Di [3]Zhang;Mingru [5]Zhang;Xiu-Xuan [1]Sun;Likun [3]Ding;Kui [2]Zhang;Junfeng [2]Jia;Jin [2]Ding;Zhiqin [2]Li;Yanyan [3]Jia;Lin-Na [8]Liu;Zhe [6]Zhang;Zhao-Wei [6]Gao;Hong [4]Du;Na [4]Yao;Qing [2]Wang;Ke [1]Wang;Jie-Jie [1]Geng;Bin [1]Wang;Ting [1]Guo;Ruo [1]Chen;Yu-Meng [1]Zhu;Li-Juan [1]Wang;Qian [1]He;Rui-Rui [1]Yao;Ying [1]Shi;Xiang-Min [1]Yang;Jian-Sheng [1]Zhou;Yi-Nan [1]Ma;Ya-Tao [1]Wang;Xue [1]Liang;Fei [1]Huo;Zhe [9]Wang;Yang [1]Zhang;Xu [1]Yang;Ye [4]Zhang;Lu-Hua [4]Gao;Ling [7]Wang;Xiao-Chun [10]Chen;Hao [10]Tang;Shuang-Shuang [10]Liu;Qing-Yi [11]Wang;Zhi-Nan [1]Chen;Ping [2]Zhu 高影响力作者 机构地区：[1]National Translational Science Center for Molecular Medicine and Department of Cell Biology,Fourth Military Medical University,Xi'an,China;[2]Department of Clinical Immunology,Xijing Hospital,Fourth Military Medical University,Xi'an,China;[3]Department of Pharmacy,Xijing Hospital,Fourth Military Medical University,Xi'an,China;[4]Center for Infectious Diseases,Tangdu Hospital,Fourth Military Medical University,Xi'an,China;[5]Department of Nuclear Medicine,Xijing Hospital,Fourth Military Medical University,Xi'an,China;[6]department of Clinical Diagnosis,Tangdu Hospital,Fourth Military Medical University,XKan,China;[7]College of Military Preventive Medicine,Fourth Military Medical University,Xi'an,China;[8]Department of Pharmaceutics,Tangdu Hospital,Fourth Military Medical University,Xi'an,China;[9]Department of Pathology,Fourth Military Medical University,Xi'an,China;[10]Jiangsu Pacific Meinuoke Biopharmaceutical Co.Ltd,Changzhou,China;[11]Department of Foreign Languages,Fourth Military Medical University,Xi'an,China高影响力机构 出　　处：《Signal Transduction and Targeted Therapy》索引2021年第6卷第6期,共11页高影响力期刊 基　　金：the China National Science and Technology Major Project(2019ZX09732-001). 摘　　要：Recent evidence suggests that CD147 serves as a novel receptor for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)infection.Blocking CD147 via anti-CD147 antibody could suppress the in vitro SARS-CoV-2 replication.Meplazumab is a humanized anti-CD147 IgG_(2) monoclonal antibody,which may effectively prevent SARS-CoV-2 infection in coronavirus disease 2019(COVID-19)patients.Here,we conducted a randomized,double-blinded,placebo-controlled phase 1 trial to evaluate the safety,tolerability,and pharmacokinetics of meplazumab in healthy subjects,and an open-labeled,concurrent controlled add-on exploratory phase 2 study to determine the efficacy in COVID-19 patients.In phase 1 study,59 subjects were enrolled and assigned to eight cohorts,and no serious treatment-emergent adverse event(TEAE)or TEAE grade≥3 was observed.The serum and peripheral blood Cmax and area under the curve showed non-linear pharmacokinetic characteristics.No obvious relation between the incidence or titer of positive anti-drug antibody and dosage was observed in each cohort.The biodistribution study indicated that meplazumab reached lung tissue and maintained>14 days stable with the lung tissue/cardiac blood-pool ratio ranging from 0.41 to 0.32.In the exploratory phase 2 study,17 COVID-19 patients were enrolled,and 11 hospitalized patients were involved as concurrent control.The meplazumab treatment significantly improved the discharged(P=0.005)and case severity(P=0.021),and reduced the time to virus negative(P=0.045)in comparison to the control group.These results show a sound safety and tolerance of meplazumab in healthy volunteers and suggest that meplazumab could accelerate the recovery of patients from COVID-19 pneumonia with a favorable safety profile. 关 键 词：PATIENTS DOSAGE PHASE
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