Dongguan Baolijian Bioengineering Research And Development Co Ltd

To explore the reasonable dose of recombinant human erythropoietin (Fc) fusion protein injection for the treatment of renal anemia in patients with chronic kidney disease on hemodialysis/peritoneal dialysis, and provide a basis for Phase III clinical trials.

Using recombinant insulin secretagogue injection (0.25 mg/ml, 2.4 ml/vial) produced by Beijing Bokangjian Gene Technology Co., Ltd. as the test preparation, recombinant insulin secretagogue for injection (10 μg/vial) produced by Beijing Bokangjian Gene Technology Co., Ltd. as reference preparation 1, and exenatide injection (0.25 mg/ml, 2.4 ml/vial) produced by Baxter Pharmaceutical Solutions LLC (license holder: AstraZeneca AB) as reference preparation 2, the relative bioavailability of the test preparation and the reference preparation after a single subcutaneous injection in healthy subjects was evaluated, and the possibility of bioequivalence between the test preparation and the reference preparation was preliminarily evaluated, so as to provide a reference basis for the design of the formal bioequivalence study of this drug.

Primary objective: To evaluate the safety and tolerability of single-dose ascending administration of recombinant human erythropoietin (Fc) fusion protein injection in healthy volunteers and compare it with placebo. Secondary objectives: 1. Determine the pharmacokinetic parameters of subcutaneous administration of recombinant human erythropoietin (Fc) fusion protein injection in healthy volunteers. 2. Determine the pharmacodynamic and immunogenic characteristics of subcutaneous ascending administration of recombinant human erythropoietin (Fc) fusion protein injection in healthy volunteers.