[Translation] A randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of DYX116 after single or multiple subcutaneous injections in healthy, overweight or obese subjects in China
主要目的
1) 评估健康/超重成人单次皮下注射DYX116后的安全性和耐受性。
2) 评估超重/肥胖成人多次皮下注射DYX116后的安全性和耐受性。
次要目的
1) 评估单次或多次皮下注射DYX116后的药代/药效动力学特征。
2) 评估健康/超重/肥胖成人皮下注射DYX116对QTc间期的影响。
3) 评估健康/超重/肥胖成人皮下注射DYX116后的免疫原性。
[Translation] Primary objectives
1) To evaluate the safety and tolerability of DYX116 after a single subcutaneous injection in healthy/overweight adults.
2) To evaluate the safety and tolerability of DYX116 after multiple subcutaneous injections in overweight/obese adults.
Secondary objectives
1) To evaluate the pharmacokinetic/pharmacodynamic characteristics of DYX116 after single or multiple subcutaneous injections.
2) To evaluate the effect of subcutaneous injection of DYX116 on the QTc interval in healthy/overweight/obese adults.
3) To evaluate the immunogenicity of DYX116 after subcutaneous injection in healthy/overweight/obese adults.