[Translation] Evaluation of the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of THDBH120 for injection in healthy Chinese adults: a randomized, double-blind, placebo-controlled, single- and multiple-dose escalation phase I clinical study
主要目的:评估健康成人单次皮下注射THDBH120后的安全性和耐受性;评估健康成人多次皮下注射THDBH120后的安全性和耐受性;
次要目的:评估健康成人单次皮下注射THDBH120后的药代/药效动力学特征;评估健康成人多次皮下注射THDBH120后的药代/药效动力学特征;评估健康成人多次皮下注射THDBH120对胃排空的影响;评估健康成人皮下注射THDBH120对QTc间期的影响;评估健康成人皮下注射THDBH120后的免疫原性。
[Translation] Primary objective: To evaluate the safety and tolerability of THDBH120 after a single subcutaneous injection in healthy adults; To evaluate the safety and tolerability of THDBH120 after multiple subcutaneous injections in healthy adults;
Secondary objectives: To evaluate the pharmacokinetic/pharmacodynamic characteristics of THDBH120 after a single subcutaneous injection in healthy adults; To evaluate the pharmacokinetic/pharmacodynamic characteristics of THDBH120 after multiple subcutaneous injections in healthy adults; To evaluate the effect of multiple subcutaneous injections of THDBH120 on gastric emptying in healthy adults; To evaluate the effect of subcutaneous injection of THDBH120 on QTc interval in healthy adults; To evaluate the immunogenicity of THDBH120 after subcutaneous injection in healthy adults.