[Translation] A single-center, dose-escalation, two-phase study evaluating the safety, tolerability, and pharmacokinetic/pharmacodynamic properties of a single intravenous dose and continuous intravenous infusion of MFS-16 for injection in healthy participants.
主要目的:评价注射用 MFS-16 在健康参与者中的安全性和耐受性。 次要目的: (1) 评价注射用 MFS-16 在健康参与者中单次静脉给药和静脉持续输注给药的药效
动力学(PD)和药代动力学(PK)特征; (2) 评价注射用 MFS-16 在健康参与者中单次静脉给药和静脉持续输注给药对
QT/QTc 间期的影响; (3) 评价注射用 MFS-16 在健康参与者中单次静脉给药的物质平衡及代谢转化。
[Translation] Primary objective: To evaluate the safety and tolerability of MFS-16 for injection in healthy participants. Secondary objectives: (1) To evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) characteristics of single intravenous administration and continuous intravenous infusion of MFS-16 for injection in healthy participants; (2) To evaluate the effects of single intravenous administration and continuous intravenous infusion of MFS-16 for injection on the QT/QTc interval in healthy participants; (3) To evaluate the substance balance and metabolic transformation of single intravenous administration of MFS-16 for injection in healthy participants.