歌禮製藥(01672.HK)新冠口服候選藥物獲FDA批准開展Ib期臨床研究
歌禮製藥(01672.HK)公布,美國食品藥品監督管理局(FDA)已批准新冠口服候選藥物聚合(酉每)(RdRp)抑制劑ASC10的新藥臨床試驗(IND)申請,在輕度至中度新冠患者中開展Ib期臨床試驗。公司將立即啟動臨床試驗,以收集ASC10的臨床安全性、藥代動力學以及初步療效數據。
歌禮指,FDA建議歌禮直接在輕度至中度新冠患者中開展ASC10首個臨床試驗,無需開展健康受試者臨床試驗,旨在確定多劑量遞增(200毫克、400毫克或800毫克,每日兩次)的ASC10片劑在輕度至中度新冠患者中的安全性、耐受性、藥代動力學和初步療效數據,治療期為5.5天,觀察期為28天。此前,莫努匹韋獲得FDA緊急使用許可的劑量為800毫克每日兩次。
ASC10是一款口服雙前藥,由歌禮完全自主研發。
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