[Translation] Phase I clinical study on the safety, tolerability, pharmacokinetics, and pharmacodynamics of TB-D004C injection in healthy subjects after single administration and in subjects with type 2 diabetes after multiple administration
主要目的:评价TB-D004C注射液在健康受试者单次皮下注射给药后以及在2型糖尿病受试者多次皮下注射给药后的安全性、耐受性及药代动力学特征。
次要目的:评价TB-D004C注射液在健康受试者单次给药后的药效学特征;评价TB-D004C注射液在2型糖尿病受试者多次皮下注射给药后的药效学特征、胰岛素敏感性和β细胞功能。
[Translation] Primary objectives: To evaluate the safety, tolerability, and pharmacokinetic profile of TB-D004C injection after a single subcutaneous dose in healthy subjects and after multiple subcutaneous doses in subjects with type 2 diabetes.
Secondary objectives: To evaluate the pharmacodynamic profile of TB-D004C injection after a single dose in healthy subjects and to evaluate the pharmacodynamic profile, insulin sensitivity, and β-cell function of TB-D004C injection after multiple subcutaneous doses in subjects with type 2 diabetes.