[Translation] A randomized, double-blind, placebo-controlled, single/multiple dose escalation safety, tolerability and pharmacokinetic characteristics phase I clinical trial of TK-03 emulsion injection in healthy adult Chinese subjects
主要目的
1.评估健康受试者单次、多次静脉输注 TK-03 乳状注射液后的安全性和耐受性;
2.确定 TK-03 乳状注射液的最大耐受剂量(Maximal Tolerated Dose, MTD)。
次要目的
评估健康受试者单次、多次静脉输注 TK-03 乳状注射液后的药代动力学(PK)特征。
[Translation] Primary Objectives
1. To evaluate the safety and tolerability of TK-03 emulsion injection after single and multiple intravenous infusions in healthy subjects;
2. To determine the maximum tolerated dose (MTD) of TK-03 emulsion injection.
Secondary Objectives
To evaluate the pharmacokinetic (PK) characteristics of TK-03 emulsion injection after single and multiple intravenous infusions in healthy subjects.