咪喹莫特乳膏Ⅰ期临床试验

Phase Ⅰ clinical trial of imiquimod cream

目的:观察健康志愿者对咪喹莫特乳膏的耐受性。方法:进行随机自身对照研究。共选择了24例成年志愿者,分4个剂量组。咪喹莫特乳膏单剂量组(3％,5％和7.5％)和咪喹莫特乳膏(5％)多剂量组隔日1次,连续3次外用于一侧大腿内侧,另一侧大腿内侧外用赋形剂。结果:所有剂量组均有很好的耐受性,仅有1例受试音出现了轻微烧灼感,1例出现轻微瘙痒。无系统不良反应。结论:3％,5％和7.5％的咪喹莫特乳膏的安全性和耐受性好。推荐在Ⅱ期临床试验中使用5％咪喹莫特乳膏。

Objective:To study the safety and tolerability of imiquimod cream. Methods:24 Chinese healthy volunteers were divided to receive a single dose of 3% ,5% and 7.5% imiquimod cream and multiple doses of 5 % imiquimod cream was given each next day for 3 time applied to the medial part of one thigh while vehicle was applied to the other thigh. Results: Imiquimod cream was well tolerated in all groups and only 1 case of slight fever and 1 case of mild itching were observed. Conclusion: Imiquimol cream is very safe and tolerable in strength of 3 % , 5 % and 7.5%, and 5 % imiquimod cream is recommended in phase Ⅱ clinical trial.