Zhejiang Younuojin Bioengineering Co., Ltd.

Main purpose: To evaluate the safety and efficacy of the experimental drug HSA-rhGH for injection compared with the control drug rhGH injection in the treatment of prepubertal children with growth hormone deficiency, and to provide a basis for the approval of recombinant human albumin-growth hormone fusion protein for injection. Secondary objectives: 1) To evaluate the changes in pharmacodynamic (PD) parameters including insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3) levels and their standard deviation scores. 2) To evaluate the immunogenicity of recombinant human albumin-growth hormone fusion protein for injection in children with growth hormone deficiency. 3) To evaluate the pharmacokinetic characteristics of recombinant human albumin-growth hormone fusion protein for injection in children with growth hormone deficiency. Exploratory objectives: To evaluate whether recombinant human albumin-growth hormone fusion protein for injection has beneficial effects on the target population in the following ways: 1) To reduce the disease burden on the family of the subjects. 2) To improve the treatment compliance of the subjects.

Main purpose: To explore the efficacy, safety, tolerability and population pharmacokinetics of different doses of HSA-rhGH for injection in the treatment of growth disorders in children caused by endogenous growth hormone deficiency, and to determine the usage and dosage of Phase III clinical trials. Secondary objectives: 1) To evaluate the immunogenicity of HSA-rhGH for injection in pediatric patients; 2) To evaluate the PK/PD characteristics of HSA-rhGH for injection in pediatric patients; 3) To compare the efficacy, safety, PK/PD characteristics and immunogenicity of rhGH injection and HSA-rhGH for injection.

Primary objective: To evaluate the tolerability and safety of single subcutaneous injection of increasing doses of recombinant human albumin-growth hormone fusion protein for injection in healthy male subjects. Secondary objective: To study the pharmacokinetics and pharmacodynamics of single subcutaneous injection of increasing doses of recombinant human albumin-growth hormone fusion protein for injection in healthy male subjects; To compare the pharmacokinetics and pharmacodynamics of single subcutaneous injection of recombinant human albumin-growth hormone fusion protein for injection with multiple subcutaneous injections of recombinant human growth hormone for injection in healthy male subjects.