中國抗體-B(03681.HK):SAD臨牀試驗已經完成 40名受試者參加
格隆匯1月29日丨中國抗體-B(03681.HK)公佈,關於SN1011在澳洲進行的I期臨牀試驗,公司一直在對SN1011有關單次遞增劑量(SAD)及多次遞增劑量在一組健康成人受試者中的安全性及耐受性進行臨牀試驗研究。董事會宣佈,截至1月15日,有關SAD的臨牀試驗已經完成,已有40名受試者參加了該臨牀試驗。
公告顯示,SN1011的單劑量介乎25毫克至200毫克範圍通常乃屬安全,且受試者耐受性很好。總共記錄了17例不良事件,所有事件均為輕度,概無一例為中度或嚴重。
17例不良事件中,(i)可能與SN1011相關的不良事件有2例(即惡夢及睏倦);(ii)3例不良事件(即打嗝、頭痛及心電圖點刺激)可能與SN1011無關;及(iii)12例不良事件與SN1011無關。上述不良事件所致受試者出現的所有症狀均已緩解或恢復,且均無發現與SN1011有明顯的劑量依賴性關係。
據悉,各種不良事件的比例如下:5例(29%)與ECG操作有關,6例(35%)與疼痛有關,及1例(6%)與惡夢、睏倦、咳嗽、打嗝、腸胃氣脹及右手背出現水腫有關。有關藥代動力學數據,初步分析表明,在介乎25毫克至200毫克的單劑量範圍內,SN1011的血漿峯值濃度(即峯值血漿濃度)隨劑量線性增加。
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