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開拓藥業-B(09939.HK):福瑞他恩治療痤瘡中國II期臨牀試驗完成首例患者給藥
格隆匯 01-24 20:35

格隆匯1月24日丨開拓藥業-B(09939.HK)公吿,其自主研發、潛在全球同類首創的福瑞他恩(KX-826)治療痤瘡中國II期臨牀試驗已於2022年1月24日完成首例患者入組及給藥。

福瑞他恩治療痤瘡在中國開展的臨牀試驗為I期、II期臨牀試驗融合設計。II期臨牀試驗是一項多中心、隨機、雙盲、安慰劑對照研究,計劃納入160名輕、中度尋常性痤瘡患者(包括男女性),以評估福瑞他恩凝膠在輕、中度尋常性痤瘡患者中外用給藥後的安全性和有效性。II期臨牀試驗的主要終點為治療12周時,各組受試者的治療成功率(根據研究者總體評分-IGA評分)。本試驗計劃在國內6家中心開展,主要研究者(leadingPI)為復旦大學附屬華山醫院項蕾紅教授。

福瑞他恩治療痤瘡I期臨牀試驗已完成,初步驗證了其在劑量爬坡和一天多次外用給藥具有良好的安全性和耐受性。

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