[Translation] A Phase I dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy characteristics of single and multiple doses of YN001 in healthy Chinese subjects and multiple doses in patients with coronary atherosclerosis
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。
[Translation] The primary objective of Phase Ia is to evaluate the safety, tolerability and pharmacokinetic characteristics of single and multiple intravenous doses of YN001 in healthy Chinese subjects.
Secondary objectives: To evaluate the effects of single intravenous doses of YN001 on the QT/QTc interval and the immunogenicity of multiple intravenous doses in healthy Chinese subjects.
The primary objective of Phase Ib is to evaluate the safety and tolerability of multiple intravenous doses of YN001 in patients with coronary atherosclerosis;
Secondary objectives: To evaluate the pharmacokinetic characteristics, preliminary efficacy, immunogenicity and cytokine changes of multiple intravenous doses of YN001 in patients with coronary atherosclerosis.