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最高研发阶段批准上市 |
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首次获批日期1982-06-28 |
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非在研适应症- |
最高研发阶段临床1/2期 |
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非在研适应症- |
最高研发阶段临床前 |
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A Phase I/IIa Trial to Evaluate the Safety, Tolerability, PK, and Preliminary Efficacy of Single and Multiple Ascending Doses of YN001 in Healthy Subjects and Multiple Ascending Doses of YN001 in Patient With Coronary Atherosclerosis
This study consists of two parts. The SAD and MAD of part I are a randomized, double-blind, placebo-controlled, single and multiple ascending dose study in healthy adult subjects. The MAD expansion cohort of part I is single arm and multipal ascending dose in heallthy subjects. Part II (phase Ib/IIa) is a multicenter, randomized, controlled, open label, multiple ascending dose study in patients with coronary atherosclerosis.
一项评价YN001在中国健康受试者中单次和多次给药及冠状动脉粥样硬化患者中多次给药的安全性、耐受性、药代动力学和初步疗效特征的剂量递增I期临床试验
Ia期主要目的:在中国健康受试者中,评估YN001单次和多次静脉给药剂量递增的安全性和耐受性及药代动力学特征。
次要目的:在中国健康受试者中,评估YN001单次静脉给药剂量递增对QT/QTc间期的影响及多次静脉给药剂量递增的免疫原性。
Ib期主要目的:在冠状动脉粥样硬化患者中,评估YN001多次静脉给药剂量递增的安全性和耐受性;
次要目的:在冠状动脉粥样硬化患者中,评估YN001多次静脉给药剂量递增的药代动力学特征、初步疗效、免疫原性和细胞因子变化。
A First-in-human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenously Administered YN001 in Healthy Subjects
This will be a single center, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study in healthy adult subjects.
100 项与 北京茵诺医药科技有限公司 相关的临床结果
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100 项与 北京茵诺医药科技有限公司 相关的药物交易
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