[Translation] A randomized, double-blind, phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity of recombinant human FGF21-Fc fusion protein for injection (AP025) 50 mg once a week for 12 consecutive weeks in Chinese adult subjects with dyslipidemia
主要目的: 评估AP025 50mg QW在血脂异常受试者中多次给药后的安全性、耐受性。
次要目的:
评估AP025 50mg QW在血脂异常受试者中多次给药后的药代动力学特性。
评估AP025 50mg QW在血脂异常受试者中多次给药后的免疫原性特征。
评估AP025 50mg QW在血脂异常受试者中多次给药后的药效学特征。
[Translation] Primary objective: To evaluate the safety and tolerability of AP025 50mg QW after multiple dosing in subjects with dyslipidemia.
Secondary objectives:
To evaluate the pharmacokinetic properties of AP025 50mg QW after multiple dosing in subjects with dyslipidemia.
To evaluate the immunogenicity characteristics of AP025 50mg QW after multiple dosing in subjects with dyslipidemia.
To evaluate the pharmacodynamic characteristics of AP025 50mg QW after multiple dosing in subjects with dyslipidemia.