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Ⅰ期耐受性试验是初步的人体安全性评价试验,其目的是研究人体对药物的耐受程度,确定安全耐受的人用剂量并了解在此剂量下的不良反应,为Ⅱ期临床试验给药提供安全的剂量范围。其方案制定的主要依据是动物的药理、毒理资料,而人与动物之间存在物种差异,试验过程中不良事件的发生率和不可预见性的风险比重较大,因此Ⅰ期耐受性试验中不良事件监测极为重要。
The Phase I Tolerance Test is a preliminary human safety evaluation test. Its purpose is to study the degree of tolerance of the human body to a drug, to determine a safe tolerated dose for human use, and to understand adverse reactions at this dose. This is a Phase II clinical trial. Dosing provides a safe dose range. The main basis for the formulation of the protocol is animal pharmacology and toxicology data, and there are species differences between humans and animals. The risk of adverse events and unpredictable risks during the trial is greater, so the Phase I tolerability test Monitoring of adverse events in China is extremely important.