评价每周期皮下注射MW05或津优力®在乳腺癌患者中预防化疗引起的中性粒细胞减少症的多中心、随机、双盲、阳性药平行对照的有效性、安全性和免疫原性的II/III期临床研究
[Translation] A multicenter, randomized, double-blind, active-drug parallel-controlled Phase II/III clinical study to evaluate the efficacy, safety, and immunogenicity of subcutaneous injection of MW05 or Jinyouli® per cycle in preventing chemotherapy-induced neutropenia in breast cancer patients
以津优力®作为阳性对照,比较MW05在乳腺癌患者中预防化疗引起的中性粒细胞减少症的有效性、安全性和免疫原性。
[Translation] Using Jinyouli® as a positive control, the efficacy, safety and immunogenicity of MW05 in preventing chemotherapy-induced neutropenia in breast cancer patients were compared.
对乳腺癌患者的耐受性、药代动力学/药效动力学及初步疗效研究
[Translation] Tolerability, pharmacokinetics/pharmacodynamics and preliminary efficacy studies in breast cancer patients
主要研究目的 评价GW003在乳腺癌患者中的耐受性及安全性。
次要研究目的 揭示GW003在乳腺癌患者中的药代动力学/药效动力学特征,为Ⅱ期临床研究推荐合理的给药方案和依据。 揭示GW003在乳腺癌患者中的初步疗效。
[Translation] Main research objectives To evaluate the tolerability and safety of GW003 in breast cancer patients.
Secondary research objectives To reveal the pharmacokinetic/pharmacodynamic characteristics of GW003 in breast cancer patients and recommend a reasonable dosing regimen and basis for Phase II clinical studies. To reveal the preliminary efficacy of GW003 in breast cancer patients.
健康受试者单次给药耐受性及药代动力学/药效动力学研究
[Translation] Single-dose tolerability and pharmacokinetic/pharmacodynamic studies in healthy subjects
主要研究目的:评价GW003在中国健康人群单次给药的耐受性及安全性。
次要研究目的:揭示GW003在健康受试者中的药代动力学/药效动力学特征,为I期及II期临床研究推荐合理的给药方案和依据。
[Translation] Main research purpose: To evaluate the tolerability and safety of a single dose of GW003 in healthy Chinese subjects.
Secondary research purpose: To reveal the pharmacokinetic/pharmacodynamic characteristics of GW003 in healthy subjects and recommend a reasonable dosing regimen and basis for Phase I and Phase II clinical studies.
100 Clinical Results associated with Taizhou Beijin Biotechnology Co., Ltd.
0 Patents (Medical) associated with Taizhou Beijin Biotechnology Co., Ltd.
100 Deals associated with Taizhou Beijin Biotechnology Co., Ltd.
100 Translational Medicine associated with Taizhou Beijin Biotechnology Co., Ltd.