A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Regeneron Anti-SARS-CoV-2 Monoclonal Antibody (a COVID-19 Therapeutic) in Adult Healthy Volunteers

Regeneron Pharmaceuticals1 个研究点分布在 1 个国家目标入组 48 人开始时间: 2022年9月15日最近更新: 2023年7月27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: 48
试验地点: 1
主要终点: Occurrence and severity of all 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 primary objective of the study is to evaluate the safety and tolerability of REGN14284 in healthy participants, as measured by all treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs).

The secondary objectives of the study are:

To assess the concentration-time profile of REGN14284 in serum
To assess the immunogenicity of REGN14284

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 60 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Has SARS-CoV-2-negative test result from a sample collected ≤72 hours prior to randomization as described in the protocol.
•Has received complete primary series of standard-of-care COVID-19 vaccination per local guidance, completed at least 2 weeks prior to screening
•Has a body mass index (BMI) between 18 and 31 kg/m2 (inclusive) at the screening visit
•Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, laboratory safety testing and ECGs performed at screening and/or prior to administration of study drug

排除标准

•History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, infectious, autoimmune, oncologic, psychiatric or neurological disease, as assessed by the investigator as described in the protocol
•Presents any concern to the 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 the screening visit
•Has a history of alcohol or drug abuse as determined by the investigator
•Has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction to drugs or food as described in the protocol
•Use of any medications or nutritional supplements within approximately 5 half-lives or 2 weeks, whichever is longer, prior to first administration of the study drug through the end of the study, except for the permitted medications listed as described in the protocol
•Participated in any clinical research study evaluating another investigational drug including biologics or specific immunotherapy, within at least 5 half-lives or 90 days (whichever is longer) of an investigational biologic drug, or at least 4 weeks for small molecules or other investigational drugs, prior to the screening visit
•NOTE: Other protocol defined inclusion / exclusion criteria apply