通化東寶(600867.SH):GLP-1/GIP雙靶點受體激動劑獲得降糖適應症Ib期臨牀試驗總結報告
格隆匯2月25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(簡稱“東寶紫星”)完成了一項關鍵Ib期臨牀試驗並獲得臨牀試驗總結報告,研究結果顯示達到主要終點目標。公司在獲得注射用THDBH120藥物臨牀試驗批準後,根據國內化學藥品創新藥相關指導原則,近日完成了一項“在中國成人2型糖尿病患者中評價注射用THDBH120多次給藥的安全性、耐受性、藥代動力學和藥效動力學的隨機、雙盲、安慰劑對照的Ib期臨牀研究”,研究結果達到了主要終點目標。試驗結果顯示,2型糖尿病受試者的PK特徵與健康受試者相似,半衰期與同靶點產品替爾泊肽相比明顯延長。注射用THDBH120多次給藥後安全性、耐受性良好,無受試者因不良事件終止用藥或退出研究,胃腸道不良反應特徵與同類產品相似,噁心、嘔吐等不良事件多爲輕度或中度。
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