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Clinical Trials associated with Recombinant Peglated human erythropoietin(China Resources Angde Biotech Pharma Co., Ltd.)聚乙二醇重组人促红素注射液(CHO细胞)在规律透析肾性贫血患者中进行维持治疗的最佳剂量和给药方案的有效性、安全性、药代动力学和药效学Ⅱ期临床研究
[Translation] Phase II clinical study on the efficacy, safety, pharmacokinetics and pharmacodynamics of the optimal dose and administration regimen of polyethylene glycol recombinant human erythropoietin injection (CHO cells) for maintenance treatment in patients with renal anemia undergoing regular dialysis
主要研究目的:
探索规律透析肾性贫血患者转换为聚乙二醇重组人促红素注射液(CHO细胞)维持治疗的最佳剂量和给药方案。
次要研究目的:
(1) 评价聚乙二醇重组人促红素注射液(CHO细胞)在规律透析肾性贫血患者中长期用药的有效性和安全性;
(2) 评价聚乙二醇重组人促红素注射液(CHO细胞)在规律透析肾性贫血患者中的药代动力学、药效学及免疫原性特征。
[Translation] Main study objectives:
To explore the optimal dose and administration regimen for patients with renal anemia undergoing regular dialysis to switch to maintenance therapy with polyethylene glycol recombinant human erythropoietin injection (CHO cells).
Secondary study objectives:
(1) To evaluate the efficacy and safety of polyethylene glycol recombinant human erythropoietin injection (CHO cells) in patients with renal anemia undergoing regular dialysis;
(2) To evaluate the pharmacokinetic, pharmacodynamic and immunogenic characteristics of polyethylene glycol recombinant human erythropoietin injection (CHO cells) in patients with renal anemia undergoing regular dialysis.
聚乙二醇重组人促红素注射液(CHO细胞)在中国健康成年受试者中单次给药的安全性、耐受性、药代动力学和药效学临床试验
[Translation] A clinical trial on the safety, tolerability, pharmacokinetics and pharmacodynamics of a single-dose polyethylene glycol recombinant human erythropoietin injection (CHO cells) in healthy Chinese adult subjects
主要目的:评价聚乙二醇重组人促红素注射液(CHO细胞)单次给药对中国健康受试者的安全性、耐受性。
次要目的:
(1)评价聚乙二醇重组人促红素注射液(CHO细胞)单次给药对中国健康受试者体内的药代动力学特征;
(2)初步评价聚乙二醇重组人促红素注射液(CHO细胞)单次给药对中国健康受试者体内的药效学特征;
(3)初步评价聚乙二醇重组人促红素注射液(CHO 细胞)单次给药对中国健康受试者的免疫原性;
[Translation] Primary objective: To evaluate the safety and tolerability of a single dose of polyethylene glycol recombinant human erythropoietin injection (CHO cells) in healthy Chinese subjects.
Secondary objectives:
(1) To evaluate the pharmacokinetic characteristics of a single dose of polyethylene glycol recombinant human erythropoietin injection (CHO cells) in healthy Chinese subjects;
(2) To preliminarily evaluate the pharmacodynamic characteristics of a single dose of polyethylene glycol recombinant human erythropoietin injection (CHO cells) in healthy Chinese subjects;
(3) To preliminarily evaluate the immunogenicity of a single dose of polyethylene glycol recombinant human erythropoietin injection (CHO cells) in healthy Chinese subjects;
100 Clinical Results associated with Recombinant Peglated human erythropoietin(China Resources Angde Biotech Pharma Co., Ltd.)
100 Translational Medicine associated with Recombinant Peglated human erythropoietin(China Resources Angde Biotech Pharma Co., Ltd.)
100 Patents (Medical) associated with Recombinant Peglated human erythropoietin(China Resources Angde Biotech Pharma Co., Ltd.)
100 Deals associated with Recombinant Peglated human erythropoietin(China Resources Angde Biotech Pharma Co., Ltd.)