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MechanismTetanus toxin inhibitors |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date19 Dec 2023 |
马破伤风免疫球蛋白(F(ab’)2)预防破伤风的有效性和安全性的随机、双盲、平行、阳性对照多中心临床试验
[Translation] A randomized, double-blind, parallel, active-controlled multicenter clinical trial of the efficacy and safety of equine tetanus immunoglobulin (F(ab')2) in the prevention of tetanus
验证马破伤风免疫球蛋白(F(ab’)2)用于预防破伤风感染短期被动免疫的有效性和安全性。
[Translation] To validate the efficacy and safety of equine tetanus immunoglobulin (F(ab')2) for short-term passive immunization against tetanus infection.
马破伤风免疫球蛋白(F(ab’)2)人体药代动力学试验
[Translation] Equine tetanus immunoglobulin (F(ab')2) human pharmacokinetics study
阐明健康受试者经单次给予马破伤风免疫球蛋白(F(ab’)2)后药物在体内经时过程,阐明本药在人体药代动力学特征,并和已上市的马破伤风免疫球蛋白进行比较,为临床用药提供依据;同时收集整个试验过程中的皮试阳性率及过敏性等不良事件、医学评价实验室安全性检查等来监测整个过程的安全性。
[Translation] To clarify the time course of the drug in vivo after a single administration of equine tetanus immunoglobulin (F(ab')2) to healthy subjects, to clarify the pharmacokinetic characteristics of this drug in humans, and to compare it with the marketed equine tetanus immunoglobulin (F(ab')2) Immune globulin is compared to provide a basis for clinical medication; at the same time, the positive rate of skin test and adverse events such as allergy during the whole test process, medical evaluation laboratory safety inspection, etc. are collected to monitor the safety of the whole process.
马破伤风免疫球蛋白(F(ab’)2)和阳性药物皮试阳性发生率对比观察研究
[Translation] A comparative observational study on the incidence rate of equine tetanus immunoglobulin (F(ab')2) and positive drug skin test
以上市马破伤风免疫球蛋白(F(ab’)2)和破伤风抗毒素注射剂为阳性对照,观察受试者自身交叉使用玉溪九洲生物技术有限责任公司生产的马破伤风免疫球蛋白(F(ab’)2)的皮试阳性率,以考察药物的安全性并为后期临床试验方案设计提供参考数据。
[Translation] Taking listed equine tetanus immunoglobulin (F(ab')2) and tetanus antitoxin injection as positive controls, the subjects themselves were observed to cross-use equine tetanus immunoglobulin (F(ab')2) produced by Yuxi Jiuzhou Biotechnology Co., Ltd. (ab') 2) skin test positive rate to investigate the safety of the drug and provide reference data for the design of late-stage clinical trial programs.
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