[Translation] A single-center, randomized, double-blind, placebo-controlled phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics of a single-dose escalation of suxindine sulfate injection in healthy Chinese subjects
主要目的: 评价硫酸舒欣啶注射液单次静脉滴注给药在中国健康受试者中的安全性、耐受性。
次要目的:评价硫酸舒欣啶注射液单次静脉滴注给药在中国健康受试者中的药代动力学 (PK) 特征;探索硫酸舒欣啶注射液在中国健康受试者中的药效学(PD)特征。
[Translation] Primary objective: To evaluate the safety and tolerability of a single intravenous infusion of suxindine sulfate injection in healthy Chinese subjects.
Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of a single intravenous infusion of suxindine sulfate injection in healthy Chinese subjects; to explore the pharmacodynamic (PD) characteristics of suxindine sulfate injection in healthy Chinese subjects.