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科笛-B(02487.HK)表皮麻醉乳膏劑III期臨床試驗達到主要終點
阿思達克 01-31 08:32
科笛-B(02487.HK)公布,其CU-30101,一種用於皮膚表皮手術的局部利多卡因丁卡因複合表皮麻醉乳膏劑,在中國進行的III期臨床試驗達到主要終點。 公司指出,CU-30101在中國的III期臨床試驗共入組286名中國成年受試者,是一項隨機、多中心、雙盲、陽性藥對照和配對設計的試驗,以評估CU-30101用於皮膚表皮手術局部鎮痛的安全性及療效。 該臨床試驗顯示出CU-30101的整體安全性良好,無重度不良事件或嚴重不良事件發生。CU-30101側與Pliaglis側的局部耐受性評估情況相近,且與Pliaglis已知的安全性特徵一致。
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