A single ascending dose, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MDCO-216 infusion in healthy volunteers and in patients with known stable coronary artery disease - MDCO-216 in healthy volunteers & patients with proven stable CAD

Medicines Company0 个研究点目标入组 48 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•Healthy volunteers:
•Males or females, 18-55 years of age, without clinically significant abnormalities who are willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures;Patients
•Male or female patients 45 - 80 years of age with proven stable atherosclerotic coronary artery disease who are willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures

•Healthy volunteers:
•Use of medication or over-the-counter substances; any surgical or medical condition which, in the judgment of the Investigator, might interfere with the pharmacokinetics, distribution, metabolism, or excretion of the study drug.;Patients:
•Myocardial infarct within the last 6 months; Any percutaneous revascularization within the last 6 months; Cerebral ischemic event defined as stroke or transient ischemic attack within the last 1 year; any surgical or medical condition which, in the judgment of the Investigator, might interfere with the pharmacokinetics, distribution, metabolism, or excretion of the study drug.

发起方

Medicines Company