Shenzhen Sciprogen Bio-Pharmaceutical Co., Ltd.

Primary objective: To evaluate the efficacy and safety of the investigational drug (RD01) at different doses and frequencies for maintenance therapy after anemia correction. Secondary objectives: (1) To evaluate the PK/PD characteristics of RD01 at different doses, frequencies, and routes of administration and the bioavailability of subcutaneous injection; (2) To explore the optimal starting dose and dosing frequency of RD01 for anemia correction or maintenance therapy (replacing conventional erythropoietin).

The nadroparin calcium injection produced by Shenzhen Saibaoer Biopharmaceutical Co., Ltd. was used as the test preparation, and the nadroparin calcium injection produced by GlaxoSmithKline was used as the reference preparation. The pharmacodynamic parameters after a single subcutaneous injection of the test preparation or the reference preparation under fasting conditions were studied, and the pharmacodynamic bioequivalence of the two preparations was evaluated according to the relevant regulations of the bioequivalence test. The safety of the test preparation nadroparin calcium injection and the reference preparation in healthy subjects was investigated.