rHSA/GCSF预防化疗引起的中性粒细胞减少症的有效性和安全性Ⅱb期临床研究
[Translation] Phase Ⅱb clinical study on the efficacy and safety of rHSA/GCSF in preventing chemotherapy-induced neutropenia
评价注射用重组人血清白蛋白/粒细胞刺激因子融合蛋白预防化疗引起的中性粒细胞减少症的有效性和安全性,为Ⅲ期临床试验安全和有效的给药方案提供依据。
[Translation] To evaluate the efficacy and safety of recombinant human serum albumin/granulocyte stimulating factor fusion protein for injection in preventing chemotherapy-induced neutropenia and to provide a basis for safe and effective dosing regimens in phase III clinical trials.
《注射用重组人血清白蛋白/粒细胞刺激因子融合蛋白》新药用于治疗化疗后粒细胞减少症的I期临床试验
[Translation] Phase I clinical trial of the new drug "Recombinant human serum albumin/granulocyte stimulating factor fusion protein for injection" for the treatment of neutropenia after chemotherapy
本Ⅰ期临床试验研究方案,旨在获得该药安全性、耐受性、初步有效剂量和药代动力学方面资料,为Ⅱ期临床研究的进行提供科学依据。
[Translation] The research plan of this Phase I clinical trial aims to obtain data on the drug's safety, tolerability, initial effective dose and pharmacokinetics, and provide a scientific basis for the conduct of Phase II clinical research.
/ Not yet recruitingPhase 1 注射用重组人血清白蛋白/促红素融合蛋白单次给药、剂量递增的耐受性、安全性、药代动力学和药效学临床试验
[Translation] Clinical trial on the tolerability, safety, pharmacokinetics and pharmacodynamics of single-dose and dose-escalation recombinant human serum albumin/erythropoietin fusion protein for injection
(1) 评价rHSA/EPO对健康受试者的安全性和耐受性; (2) 考察rHSA/EPO在健康受试者体内的药代动力学特性,获取初步药代动力学参数。
[Translation] (1) To evaluate the safety and tolerability of rHSA/EPO in healthy subjects; (2) To investigate the pharmacokinetic properties of rHSA/EPO in healthy subjects and obtain preliminary pharmacokinetic parameters.
100 Clinical Results associated with Tianjin PuYing Biotechnology Co., Ltd.
0 Patents (Medical) associated with Tianjin PuYing Biotechnology Co., Ltd.
100 Deals associated with Tianjin PuYing Biotechnology Co., Ltd.
100 Translational Medicine associated with Tianjin PuYing Biotechnology Co., Ltd.