[Translation] A Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple subcutaneous injections of UBT251 in overweight/obese patients
主要目的:评价超重/肥胖受试者多次皮下注射UBT251的安全性和耐受性(包含局部耐受性)。
次要目的:评价超重/肥胖受试者多次皮下注射UBT251注射液后的PK/PD特征;评价超重/肥胖受试者多次皮下注射UBT251注射液后的初步疗效;评价超重/肥胖受试者多次皮下注射UBT251注射液后的免疫原性。
探索性目的:探索超重/肥胖受试者多次皮下注射UBT251注射液后对食欲的影响;探索超重/肥胖受试者多次皮下注射UBT251注射液对QT/QTc间期的影响。
[Translation] Primary objective: To evaluate the safety and tolerability (including local tolerance) of multiple subcutaneous injections of UBT251 in overweight/obese subjects.
Secondary objectives: To evaluate the PK/PD characteristics of overweight/obese subjects after multiple subcutaneous injections of UBT251 injection; To evaluate the preliminary efficacy of overweight/obese subjects after multiple subcutaneous injections of UBT251 injection; To evaluate the immunogenicity of overweight/obese subjects after multiple subcutaneous injections of UBT251 injection.
Exploratory objectives: To explore the effect of multiple subcutaneous injections of UBT251 injection on appetite in overweight/obese subjects; To explore the effect of multiple subcutaneous injections of UBT251 injection on QT/QTc interval in overweight/obese subjects.