医学
药代动力学
2019年冠状病毒病(COVID-19)
中和
效力
单克隆抗体
严重急性呼吸综合征冠状病毒2型(SARS-CoV-2)
效价
不利影响
抗体
药效学
病毒学
临床终点
临床试验
中和抗体
药理学
肌肉注射
分布(数学)
免疫学
作者
Simone Lanini,Stefano Milleri,Emanuele Andreano,Sarah Nosari,Ida Paciello,Giulia Piccini,Alessandra Gentili,Adhuna Phogat,Inesa Hyseni,Margherita Leonardi,Alessandro Torelli,Emanuele Montomoli,Andrea Paolini,Andrea Frosini,Andrea Antinori,Emanuele Nicastri,Enrico Girardi,Maria Maddalena Plazzi,Giuseppe Ippolito,Francesco Vaia,Giovanni Della Cioppa,Rappuoli R
标识
DOI:10.1038/s41467-022-29909-x
摘要
The emerging threat represented by SARS-CoV-2 variants, demands the development of therapies for better clinical management of COVID-19. MAD0004J08 is a potent Fc-engineered monoclonal antibody (mAb) able to neutralize in vitro all current SARS-CoV-2 variants of concern (VoCs) including the omicron variant even if with significantly reduced potency. Here we evaluated data obtained from the first 30 days of a phase 1 clinical study (EudraCT N.: 2020-005469-15 and ClinicalTrials.gov Identifier: NCT04932850). The primary endpoint evaluated the percentage of severe adverse events. Secondary endpoints evaluated pharmacokinetic and serum neutralization titers. A single dose administration of MAD0004J08 via intramuscular (i.m.) route is safe and well tolerated, resulting in rapid serum distribution and sera neutralizing titers higher than COVID-19 convalescent and vaccinated subjects. A single dose administration of MAD0004J08 is also sufficient to effectively neutralize major SARS-CoV-2 variants of concern (alpha, beta, gamma and delta). MAD0004J08 can be a major advancement in the prophylaxis and clinical management of COVID-19.
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