[Translation] To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic characteristics of THDBH120 for injection in healthy Chinese adults: a randomized, double-blind, placebo-controlled, single- and multiple-dose ascending 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] Main purpose: To evaluate the safety and tolerability of healthy adults after a single subcutaneous injection of THDBH120; to evaluate the safety and tolerability of healthy adults after multiple subcutaneous injections of THDBH120;
Secondary purpose: To evaluate the pharmacokinetic/pharmacodynamic characteristics of healthy adults after a single subcutaneous injection of THDBH120; to evaluate the pharmacokinetic/pharmacodynamic characteristics of healthy adults after multiple subcutaneous injections of THDBH120; to evaluate the pharmacokinetic/pharmacodynamic characteristics of healthy adults after multiple subcutaneous injections of THDBH120 Effect on gastric emptying; evaluate the effect of subcutaneous injection of THDBH120 on QTc interval in healthy adults; evaluate immunogenicity after subcutaneous injection of THDBH120 in healthy adults.