A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of REGN7544, an Antagonistic Monoclonal Antibody to NPR1, in Healthy Adults

Regeneron Pharmaceuticals1 个研究点分布在 1 个国家目标入组 80 人开始时间: 2023年8月7日最近更新: 2024年8月12日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Regeneron Pharmaceuticals
入组人数: 80
试验地点: 1
主要终点: Incidence of Treatment Emergent Adverse Events (TEAEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study is researching an experimental drug called REGN7544.The study is focused on healthy adults. The aim of the study is to see how safe and tolerable the study drug is in healthy adults.

The study is looking at several other research questions, including:

What side effects may happen from taking the study drug
How much study drug is in your blood at different times
Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Has a body mass index between 18 and 32 kg/m^2
•Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed at screening and/or prior to administration of initial dose of study drug, as defined in the protocol
•Has normal blood pressure (BP) and pulse rate readings, as defined in the protocol
•Difference between semi-recumbent systolic blood pressure (SBP) measurements in left and right arm less than 20 mmHg at screening visit

排除标准

•History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator that may confound the results of the study or poses an additional risk to the participant by study participation
•History, in the past 2 years of a diagnosis of hypertension, symptomatic hypotension (BP <90/50 mmHg with associated symptoms), symptomatic orthostatic hypotension, postural orthostatic tachycardia syndrome, syncope, or clinically significant cardiac arrhythmia
•Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
•Was hospitalized (ie, >24 hours) for any reason within 30 days of screening
•Is a current smoker or former smoker, including e-cigarettes, who stopped smoking within 3 months prior to screening
•NOTE: Other protocol defined inclusion / exclusion criteria apply