開拓藥業-B(09939.HK):福瑞他恩治療女性脱髮的中國II期臨牀試驗完成受試者入組
格隆匯3月6日丨開拓藥業-B(09939.HK)董事會宣佈,其自主研發、潛在全球同類首創的福瑞他恩(KX-826)治療女性雄激素性脱髮(AGA)的中國II期臨牀試驗於2022年3月4日完成全部160名受試者入組。自首例受試者入組至完成入組僅用時不超過4個月(包括中國春節假期),預計今年四季度發佈初步數據。
該II期臨牀試驗是一項隨機、雙盲、安慰劑對照、多中心的研究,以評估福瑞他恩治療成年女性雄激素性脱髮患者的有效性和安全性。臨牀試驗的主要終點為目標區域內非毳毛數量變化(治療24周與基線的平均變化)。該II期臨牀試驗由北京大學人民醫院擔任組長單位,在全國15家中心開展。北京大學人民醫院張建中教授作為主要研究者(leadingPI)領導這項研究。
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