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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 |
Target- |
Mechanism- |
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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
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, positive-controlled, multicenter clinical trial on the efficacy and safety of equine tetanus immune globulin (F(ab’)2) in preventing 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 verify the efficacy and safety of equine tetanus immune globulin (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] Pharmacokinetics of equine tetanus immunoglobulin (F(ab')2) in humans
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 the body after a single administration of equine tetanus immunoglobulin (F(ab')2) to healthy subjects, clarify the pharmacokinetic characteristics of this drug in humans, and compare it with the marketed equine tetanus immunoglobulin to provide a basis for clinical use; at the same time, collect the skin test positivity rate and adverse events such as allergies during the entire trial, and conduct medical evaluation laboratory safety inspections to monitor the safety of the entire 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] Comparative study on the incidence of positive skin test of equine tetanus immunoglobulin (F(ab')2) and positive drugs
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] Using the marketed equine tetanus immunoglobulin (F(ab')2) and tetanus antitoxin injection as positive controls, the skin test positivity rate of the subjects cross-using the equine tetanus immunoglobulin (F(ab')2) produced by Yuxi Jiuzhou Biotechnology Co., Ltd. was observed to examine the safety of the drug and provide reference data for the design of later clinical trial protocols.
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