重组人源抗狂犬病病毒单克隆抗体（兰州生物制品研究所）(Recombinant human anti-rabies virus monoclonal antibody (Lanzhou Institute of Biological Products))

概要

基本信息

药物类型

单克隆抗体

别名-

靶点-

作用方式-

作用机制-

治疗领域

感染其他疾病

在研适应症

狂犬病

非在研适应症-

原研机构

兰州生物制品研究所有限责任公司

在研机构

兰州生物制品研究所有限责任公司

非在研机构-

权益机构-

最高研发阶段临床1期

首次获批日期-

最高研发阶段(中国)临床1期

特殊审评-

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关联

2

项与重组人源抗狂犬病病毒单克隆抗体（兰州生物制品研究所）相关的临床试验

CTR20250090

/ Not yet recruiting临床1期

单中心、随机、盲法、对照设计评价重组人源抗狂犬病病毒单克隆抗体注射液在健康人群中应用的安全性和耐受性、药代动力学和药效学的Ⅰ期临床试验

1)评价重组人源抗狂犬病病毒单克隆抗体注射液相比狂犬病人免疫球蛋白，在18-60岁健康受试者中单独给药或与人用狂犬病疫苗联用给药的安全性、耐受性和狂犬病毒中和抗体活性（Rabies Virus Neutralizing Activity，RVNA）；2）评价重组人源抗狂犬病病毒单克隆抗体注射液在18-60岁健康受试者中单独给药或与人用狂犬病疫苗联用给药的药代动力学。

开始日期-

申办/合作机构

兰州生物制品研究所有限责任公司

ChiCTR2500098706

/ Recruiting临床1期IIT

A phase I clinical study to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of recombinant human anti-rabies virus monoclonal antibody injection solutions in healthy cohorts by a single-centre, randomised, double-blind and controlled design

开始日期2025-01-17

申办/合作机构-

100 项与重组人源抗狂犬病病毒单克隆抗体（兰州生物制品研究所）相关的临床结果

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100 项与重组人源抗狂犬病病毒单克隆抗体（兰州生物制品研究所）相关的转化医学

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100 项与重组人源抗狂犬病病毒单克隆抗体（兰州生物制品研究所）相关的专利（医药）

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2

项与重组人源抗狂犬病病毒单克隆抗体（兰州生物制品研究所）相关的文献（医药）

2022-03-01·Travel Medicine and Infectious Disease2区 · 医学

Efficacy of ormutivimab, a novel recombinant human anti-rabies monoclonal antibody, in post-exposure prophylaxis animal models

2区 · 医学

Article

作者: Wang, Hui ; Zhang, Shou-Feng ; Chen, Chen ; Gao, Jie ; Yang, Ming-Ming ; Zhao, Jing ; Zhang, Xu-Fan ; Zhang, Bin ; Lv, Ruo-Yun ; Li, Yu-Feng ; Zhang, Shi-Xiong ; Zhai, Li-Li ; Gao, Jian ; Miao, Fa-Ming ; Wei, Jing-Shuang ; Cao, Yang ; Cao, Jia-Bin ; Zhao, Wei

Human rabies is a serious public health problem that can't be ignored. Rabies immune globulin (RIG) is an indispensable component of rabies post-exposure prophylaxis (PEP). However, current PEP relies on RIG purified from pooled human or equine plasma, which are either in chronic shortage or associated with safety concerns. Monoclonal antibodies have become widely accepted as safer and more cost-effective alternatives to RIG products in recent years. Here, we assessed the neutralization breadth of human monoclonal antibody ormutivimab and its protective efficacy in PEP models. Ormutivimab was able to neutralize a broad panel of Chinese prevalent street RABVs with neutralizing potency form 198-1487.6 IU/mL. Furthermore, ormutivimab offered comparable protection to that with HRIG both at standard doses (20 IU/kg) and higher doses (100 IU/kg and 200 IU/kg). The interference of ormutivimab on vaccine potency was also analyzed and found slightly reduced neutralizing antibody titers similar to HRIG. The broad-spectrum neutralization activities, highly protective potency, and rapid onset of action make ormutivimab an effective candidate for human rabies PEP.

2013-04-01·Yao xue xue bao = Acta pharmaceutica Sinica

[Testing immunogenicity of recombinant antibody by surface plasmon resonance].

Article

作者: Liu, Yan-Ling ; Zhao, Wei ; Liu, Xiao-Zhi ; Chang, Liang ; Li, Li-Min ; Dong, Xiang-Feng ; Gao, Jian ; Jiang, Yan ; Wei, Jing-Shuang ; Chen, Xue-Jing

With the development of bio-technological drugs, drug immunogenicity evaluation has become key factor of clarifying safety and efficacy of these drugs. It has become the focus to establish a stable and reliable evaluation system. Due to the advantages such as continuous real-time monitoring, surface plasmon resonance (SPR) technology has been widely used in bio-technological drugs immunogenicity assessments. Our study applied this technology to detect anti-drug antibody (ADA) of a recombinant human anti-rabies monoclonal antibody NM57 in the sera of 48 volunteers admitted in phase I clinical trials. This method could satisfy the basic requirements of detection of ADA.

100 项与重组人源抗狂犬病病毒单克隆抗体（兰州生物制品研究所）相关的药物交易

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