[Translation] A multicenter, randomized, double-blind, placebo-controlled, dose-escalating Phase Ib clinical study to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of insulin-secreting peptide fusion protein (E4F4) injection in patients with type 2 diabetes after multiple doses
主要目的: 评价促胰岛素分泌肽融合蛋白(E4F4)注射液在2型糖尿病成人受试者中的耐受性、安全性; 评价促胰岛素分泌肽融合蛋白(E4F4)注射液在2型糖尿病成人受试者中的药代 动力学和药效动力学(PK/PD)特征。 次要目的: 为后续临床研究确定适当的给药剂量提供依据; 评价不同剂量的促胰岛素分泌肽融合蛋白(E4F4)注射液在2型糖尿病患者中多次给药后的免疫原性。 探索性目的: 依据动态血糖监测数据结果采用群体模型指导后期临床研究给药方案的设计,为后续临床研究确定适当的给药剂量提供依据。
[Translation] Primary objective: To evaluate the tolerability and safety of insulin secretion-promoting peptide fusion protein (E4F4) injection in adult subjects with type 2 diabetes; To evaluate the pharmacokinetic and pharmacodynamic (PK/PD) characteristics of insulin secretion-promoting peptide fusion protein (E4F4) injection in adult subjects with type 2 diabetes. Secondary objective: To provide a basis for determining appropriate dosing in subsequent clinical studies; To evaluate the immunogenicity of different doses of insulin secretion-promoting peptide fusion protein (E4F4) injection after multiple administration in patients with type 2 diabetes. Exploratory objective: To use a population model to guide the design of dosing regimens for later clinical studies based on the results of dynamic blood glucose monitoring data, and to provide a basis for determining appropriate dosing in subsequent clinical studies.