[Translation] A randomized, double-blind, placebo- and active drug-controlled, single- and multiple-dose ascending phase I clinical trial to investigate the safety, tolerability, and PK characteristics of the drug in healthy subjects.
主要目的:评估在健康受试者中单次和/或多次静脉给予GD-19乳状注射液的安全性和耐受性。次要目的:评价GD-19乳状注射液在健康受试者中的药代动力学特征(PK)和物质平衡。
[Translation] Primary objective: To evaluate the safety and tolerability of single and/or multiple intravenous administrations of GD-19 emulsion injection in healthy subjects. Secondary objective: To evaluate the pharmacokinetic characteristics (PK) and material balance of GD-19 emulsion injection in healthy subjects.