[Translation] A randomized, double-blind, placebo-controlled Phase Ia clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of CCIBPR01005 in healthy adult male subjects after a single dose
主要目的:评价人生长激素-Fc融合蛋白注射液在健康成年男性受试者单次皮下注射后的安全性和耐受性。
次要目的:评价人生长激素-Fc融合蛋白注射液在健康成年男性受试者单次皮下注射后的药代动力学(PK)特征。 评价人生长激素-Fc融合蛋白注射液在健康成年男性受试者单次皮下注射后的药效动力学(PD)特征。 评价人生长激素-Fc融合蛋白注射液在健康成年男性受试者单次皮下注射后的免疫原性。
[Translation] Primary objective: To evaluate the safety and tolerability of human growth hormone-Fc fusion protein injection after a single subcutaneous injection in healthy adult male subjects.
Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of human growth hormone-Fc fusion protein injection after a single subcutaneous injection in healthy adult male subjects. To evaluate the pharmacodynamic (PD) characteristics of human growth hormone-Fc fusion protein injection after a single subcutaneous injection in healthy adult male subjects. To evaluate the immunogenicity of human growth hormone-Fc fusion protein injection after a single subcutaneous injection in healthy adult male subjects.