[Translation] Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and biological effects of intravenous drug BT-114143 in healthy subjects
1.单次给药与多次给药剂量递增试验 主要目的:评估BT-114143在健康受试者中静脉注射单次给药、多次给药剂量递增的安全性和耐受性,确定II期推荐剂量(RP2D)。 次要目的:评估BT-114143在健康受试者中静脉注射单次给药、多次给药剂量递增的药代动力学特征。 探索性目的:探索BT-114143在健康受试者中的生物学效应;探索BT-114143在健康受试者中的剂量-暴露-效应关系。
2.生物学效应探索性试验 主要目的:比较BT-114143与阳性对照药物单次静脉注射在健康受试者体内的抗纤溶活性和凝血指标,尽早建立药物的剂量-暴露-效应关系,为后期临床研究设计提供依据。 次要目的:评估BT-114143和阳性对照药物在健康受试者中静脉注射给药的药代动力学特征。
[Translation] 1. Single and multiple dose escalation trials Primary objective: To evaluate the safety and tolerability of BT-114143 in healthy subjects by single intravenous administration and multiple dose escalation, and to determine the Phase II recommended dose (RP2D). Secondary objective: To evaluate the pharmacokinetic characteristics of BT-114143 in healthy subjects by single intravenous administration and multiple dose escalation. Exploratory objective: To explore the biological effects of BT-114143 in healthy subjects; to explore the dose-exposure-effect relationship of BT-114143 in healthy subjects.
2. Biological effect exploratory trial Primary objective: To compare the antifibrinolytic activity and coagulation indexes of BT-114143 and positive control drugs in healthy subjects after single intravenous administration, to establish the dose-exposure-effect relationship of the drug as early as possible, and to provide a basis for the design of later clinical studies. Secondary objective: To evaluate the pharmacokinetic characteristics of BT-114143 and positive control drugs in healthy subjects by intravenous administration.