通化东宝(600867.SH):GLP-1/GIP双靶点受体激动剂获得降糖适应症Ib期临床试验总结报告

格隆汇
25 Feb

格隆汇2月25日丨通化东宝(600867.SH)公布,全资子公司东宝紫星(杭州)生物医药有限公司(简称“东宝紫星”)完成了一项关键Ib期临床试验并获得临床试验总结报告,研究结果显示达到主要终点目标。公司在获得注射用THDBH120药物临床试验批准后,根据国内化学药品创新药相关指导原则,近日完成了一项“在中国成人2型糖尿病患者中评价注射用THDBH120多次给药的安全性、耐受性、药代动力学和药效动力学的随机、双盲、安慰剂对照的Ib期临床研究”,研究结果达到了主要终点目标。试验结果显示,2型糖尿病受试者的PK特征与健康受试者相似,半衰期与同靶点产品替尔泊肽相比明显延长。注射用THDBH120多次给药后安全性、耐受性良好,无受试者因不良事件终止用药或退出研究,胃肠道不良反应特征与同类产品相似,恶心、呕吐等不良事件多为轻度或中度。

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