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项与 雷莫西尤单抗生物类似药(复宏汉霖) 相关的临床试验A Randomized, Parallel-controlled, Intravenous Single-dose, Phase I Clinical Study Comparing the Pharmacokinetic Profile, Safety, Tolerability and Immunogenicity of HLX12 and Cyramza (Ramucirumab) in Healthy Male Adult Subjects
The study consists of 2 parts:
Part I study: to preliminarily compare the PK profile of HLX12 and Cyramza This study is an open-label, randomized, parallel-controlled, intravenous single-dose pretrial study comparing the pharmacokinetic profile, safety, tolerability and immunogenicity of HLX12 and Ramucirumab in healthy male adult subjects. The number of subjects is set to 24, who will be randomized into two groups, and each group has the same number of subjects (n=12). Group 1 will receive intravenous infusion of the test preparation T HLX12, while Group 2 will receive Cyramza, once in both groups.
Part II study: to compare the PK similarity between HLX12 and Cyramza This study is a randomized, double-blind, parallel-controlled, intravenous single-dose Phase I clinical study comparing the pharmacokinetic profile, safety, tolerability and immunogenicity of HLX12 and Ramucirumab in healthy male adult subjects.The number of subjects is set to 128, and the treatment is the same with Part I study.
随机、平行对照、单次给药、比较HLX12与Cyramza在健康男性成人中的药代动力学、安全性、耐受性、免疫原性的I期临床
在健康男性受试者中比较HLX12与Cyramza(Ramucirumab,雷莫芦单抗)在单次静脉输注后两组间(HLX12与Cyramza)药物代谢动力学(PK)方面的相似性。
100 项与 雷莫西尤单抗生物类似药(复宏汉霖) 相关的临床结果
100 项与 雷莫西尤单抗生物类似药(复宏汉霖) 相关的转化医学
100 项与 雷莫西尤单抗生物类似药(复宏汉霖) 相关的专利(医药)
100 项与 雷莫西尤单抗生物类似药(复宏汉霖) 相关的药物交易