通化東寶(600867.SH):痛風雙靶點抑制劑Ⅰ期臨牀試驗完成總結報吿
格隆匯2月22日丨通化東寶(600867.SH)公佈,全資子公司東寶紫星(杭州)生物醫藥有限公司收到國家藥品監督管理局簽發的關於痛風雙靶點XO/URAT1抑制劑(THDBH151片)藥物臨牀試驗批准通知書後,已經完成了一項關鍵I期臨牀試驗並獲得臨牀試驗總結報吿,研究結果顯示達到主要終點目標。
THDBH151片在獲得國家藥品監督管理局的藥物臨牀試驗批准後,根據國內化學藥品創新藥相關指導原則,申請人已經啟動一項“THDBH151片在健康成人受試者中單次和多次給藥的安全性、耐受性、藥代/藥效動力學及食物影響的I期臨牀研究”,目前試驗已完成,試驗結果顯示本品在中國健康成人受試者中安全性和耐受性良好,總體不良事件發生率與安慰劑相似或略低,所有不良事件均為1級。
藥效動力學指標(PD)顯示,本品可以顯著降低受試者血清尿酸水平,量效關係明顯。同時觀察到本品給藥後顯著提高血清黃嘌呤水平,且增加尿液尿酸排泄水平。顯示本品在人體內對於黃嘌呤氧化酶(XO)以及尿酸鹽轉運體(URAT1)兩個靶點同時產生抑制作用,驗證了本品系真正的XO/URAT1雙靶點抑制劑。藥代動力學指標(PK)顯示本品均有良好的藥代性質,成藥性良好,完全滿足每日一次給藥需求。
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