[Translation] A randomized, double-blind, dose-escalating, placebo-controlled Phase I clinical study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effects of single and multiple doses of ZT006 tablets in healthy, overweight, or obese subjects
主要研究目的:评估ZT006片在健康、超重或肥胖受试者中单次和多次给药后以及食物影响的安全性和耐受性。
次要研究目的:1.评估ZT006单次和多次给药后以及食物影响的药代动力学特征。2.评估单次和多次给药后ZT006片免疫原性。
探索性研究目的:评估ZT006片单次和多次给药以及食物影响研究对受试者空腹血糖、胰岛素、C肽、血脂(总胆固醇、甘油三酯、LDL、HDL)、体重的影响。
[Translation] Primary study objectives: To evaluate the safety and tolerability of ZT006 tablets after single and multiple administrations and the effects of food in healthy, overweight or obese subjects.
Secondary study objectives: 1. To evaluate the pharmacokinetic characteristics of ZT006 after single and multiple administrations and the effects of food. 2. To evaluate the immunogenicity of ZT006 tablets after single and multiple administrations.
Exploratory study objectives: To evaluate the effects of single and multiple administrations of ZT006 tablets and the effects of food on fasting blood glucose, insulin, C-peptide, blood lipids (total cholesterol, triglycerides, LDL, HDL), and body weight of subjects.