[Translation] A randomized, open-label, two-agent, two-cycle, crossover, single-dose PK/PD comparison trial of pegylated recombinant human granulocyte-stimulating factor injection in healthy subjects
主要目的:
比较健康受试者皮下注射石药集团百克(山东)生物制药股份有限公司生产的聚乙二醇化重组人粒细胞刺激因子注射液新规格6.0mg(0.6ml)/支(受试制剂)与原规格3.0mg(1.0ml)/支(参比制剂)后的PK和PD特征。
次要目的:
评价石药集团百克(山东)生物制药股份有限公司生产的的聚乙二醇化重组人粒细胞刺激因子注射液新规格与原规格皮下注射给药后在健康受试者中的免疫原性及安全性。
[Translation] main purpose:
Comparison of the new specifications of PEGylated recombinant human granulocyte-stimulating factor injection 6.0mg (0.6ml)/vii (test preparation) produced by subcutaneous injection of CSPC (Shandong) Biopharmaceutical Co., Ltd. in healthy subjects with PK and PD characteristics after the original specification of 3.0mg (1.0ml) / support (reference preparation).
Secondary purpose:
To evaluate the immunogenicity of PEGylated recombinant human granulocyte-stimulating factor injection in healthy subjects after subcutaneous injection of new and original specifications produced by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. safety.