[Translation] A multicenter, non-randomized, open-label, parallel-controlled, single-dose phase I clinical trial to evaluate the pharmacokinetic characteristics of TG103 injection in subjects with normal renal function and renal insufficiency
主要目的:
评价肾功能正常和肾功能不全受试者单次皮下注射TG103注射液后的药代动力学特征。
次要目的:
评价肾功能正常和肾功能不全受试者单次皮下注射TG103注射液后的免疫原性; 评价肾功能正常和肾功能不全受试者单次皮下注射TG103注射液后的安全性和耐受性。
[Translation] Primary purpose:
To evaluate the pharmacokinetic characteristics of TG103 injection after a single subcutaneous injection in subjects with normal renal function and renal insufficiency.
Secondary purpose:
To evaluate the immunogenicity of TG103 injection after a single subcutaneous injection in subjects with normal renal function and renal insufficiency; To evaluate the safety and tolerability of TG103 injection after a single subcutaneous injection in subjects with normal renal function and renal insufficiency.