[Translation] A randomized, double-blind, placebo-controlled, single- and multiple-dose phase I clinical trial of the safety, tolerability, and pharmacokinetics of a long-acting GLP-1/GIP dual receptor agonist (ZX2010) injection in healthy Chinese subjects
主要目的:评估在健康受试者单次和多次皮下注射ZX2010注射液后的安全性和耐受性。
次要目的:评估在健康受试者单次和多次皮下注射ZX2010注射液后药代动力学特征和免疫原性。
探索性目的:探索在健康受试者单次和多次皮下注射ZX2010注射液后初步药效学特征;探索在健康受试者单次和多次皮下注射ZX2010注射液后的QT/QTc间期情况;探索ZX2010注射液暴露与效应之间的关系。
[Translation] Primary objective: To evaluate the safety and tolerability of ZX2010 injection after single and multiple subcutaneous injections in healthy subjects.
Secondary objective: To evaluate the pharmacokinetic characteristics and immunogenicity of ZX2010 injection after single and multiple subcutaneous injections in healthy subjects.
Exploratory objective: To explore the preliminary pharmacodynamic characteristics of ZX2010 injection after single and multiple subcutaneous injections in healthy subjects; to explore the QT/QTc interval after single and multiple subcutaneous injections of ZX2010 injection in healthy subjects; to explore the relationship between exposure and effect of ZX2010 injection.