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開拓藥業(09939.HK)KX-826酊治脫髮二期臨牀試驗達主要終點
阿思達克 07-24 09:02
開拓藥業(09939.HK)宣佈,其自主研發、潛在同類首創的KX-826酊1.0%治療脫髮的關鍵性臨牀試驗二期階段已獲得頂線數據。數據顯示,該二期階段達到主要研究終點,結果具有統計學顯着性及臨牀意義,且有效性和安全性均表現出色。 該試驗爲一項多中心、隨機、雙盲、賦形劑對照的II/III期適應性設計研究,旨在評估KX-826酊1.0%及0.5%劑量對中國成年男性脫髮(AGA)患者的療效及安全性。結果經獨立數據監查委員會(IDMC)審查,其主要建議爲基於目前安全性和有效性數據,而三期階段臨牀試驗將繼續進行,組別和樣本量不變。
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