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重组人神经生长因子(ZX1305)注射液治疗视神经损伤有效性、安全性和免疫原性的Ⅱ
期临床研究
[Translation] Efficacy, safety and immunogenicity of recombinant human nerve growth factor (ZX1305) injection in the treatment of optic nerve injury Ⅱ
phase clinical study
主要研究目的:探索肌肉注射不同剂量的重组人神经生长因子(ZX1305)注射液治疗视神经损伤的有效性,为Ⅲ期临床试验设计提供依据。
次要研究目的:探索肌肉注射不同剂量的重组人神经生长因子(ZX1305)注射液治疗视神经损伤的安全性和免疫原性。
[Translation] The main purpose of the study: To explore the effectiveness of intramuscular injection of different doses of recombinant human nerve growth factor (ZX1305) injection in the treatment of optic nerve injury, and to provide a basis for the design of phase III clinical trials.
Secondary research purpose: To explore the safety and immunogenicity of intramuscular injection of different doses of recombinant human nerve growth factor (ZX1305) injection in the treatment of optic nerve injury.
重组人神经生长因子(ZX1305)注射液治疗开角型青光眼导致的视神经损伤有效性、安全性和免疫原性的II期临床研究
[Translation] Phase II clinical study on efficacy, safety and immunogenicity of recombinant human nerve growth factor (ZX1305) injection in the treatment of optic nerve injury caused by open-angle glaucoma
主要研究目的:探索肌肉注射重组人神经生长因子(ZX1305)注射液治疗开角型青光眼导致的视神经损伤的有效性,为后期临床试验设计提供依据。
次要研究目的:探索肌肉注射重组人神经生长因子(ZX1305)注射液治疗开角型青光眼导致的视神经损伤的安全性和免疫原性。
[Translation] The main purpose of the study: To explore the effectiveness of intramuscular injection of recombinant human nerve growth factor (ZX1305) injection in the treatment of optic nerve damage caused by open-angle glaucoma, and to provide a basis for the design of later clinical trials.
Secondary research purpose: To explore the safety and immunogenicity of intramuscular injection of recombinant human nerve growth factor (ZX1305) injection in the treatment of optic nerve injury caused by open-angle glaucoma.
重组人神经生长因子注射液在中国健康受试者中的安全性、耐受性和药代动力学的I期临床试验
[Translation] Phase I clinical trial of safety, tolerability and pharmacokinetics of recombinant human nerve growth factor injection in healthy Chinese subjects
考察中国健康受试者单次/多次肌肉注射重组人神经生长因子注射液后的安全性、耐受性和药代动力学特征和免疫原性,为后续临床试验提供安全的剂量范围,以及安全合理的给药方案。
[Translation] To investigate the safety, tolerability, pharmacokinetic characteristics and immunogenicity of single/multiple intramuscular injection of recombinant human nerve growth factor injection in healthy Chinese subjects, to provide a safe dose range for subsequent clinical trials, and Safe and reasonable dosing regimen.
100 Clinical Results associated with Jiangsu Zhongxin Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Jiangsu Zhongxin Pharmaceutical Co., Ltd.
100 Deals associated with Jiangsu Zhongxin Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Jiangsu Zhongxin Pharmaceutical Co., Ltd.