A Phase 1, Randomized, Open-Label Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers

Regeneron Pharmaceuticals2 个研究点分布在 1 个国家目标入组 45 人开始时间: 2022年1月7日最近更新: 2025年10月14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: 45
试验地点: 2
主要终点: Serious adverse events (SAEs)

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 assess the safety and tolerability of co-formulated subcutaneous (SC) and intravenous (IV) casirivimab+imdevimab

The secondary objectives of the study are to:

Explore variability in the drug concentration profiles of casirivimab and imdevimab after co-formulated subcutaneous (SC) or intravenous (IV) administration
Characterize the immunogenicity of casirivimab and imdevimab in serum over time

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Is healthy, or has chronic medical condition(s) that per the opinion of the investigator is (are) stable, well-controlled, and not likely to require medical intervention through the end of study
•Does not require medication(s) for co-morbid condition, or has received stable medication(s) for co-morbid condition(s) for at least 6 months prior to screening
•Weighs between ≥60 kg and ≤100 kg at the time of screening
•Has SARS-CoV-2-negative reverse-transcriptase polymerase chain reaction (RT-PCR) from a sample collected ≤72 hours prior to randomization, using local assay and sample collection and assay standards
•Has completed a full course of COVID-19 vaccination more than 6 weeks prior to randomization

排除标准

•Has active respiratory or non-respiratory symptoms consistent with COVID-19 in the opinion of the Investigator
•Has recent SARS-CoV-2 infection that resolved within 6 weeks prior to randomization
•Prior use of casirivimab+imdevimab at any time prior to randomization
•Prior, current, or planned use during the study of any of the following treatments: COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 (eg, bamlanivimab and etesevimab, sotrovimab), intravenous immunoglobulin (any indication), or any other investigational, authorized, or approved agent intended for COVID-19 treatment or prevention (with the exception of COVID-19 vaccines)
•Treatment with another investigational drug in the last 30 days or within 5 half-lives of the investigational drug, whichever is longer, prior to screening
•Body mass index (BMI) ≥28 kg/m2
•Medically-attended acute illness, systemic antibiotics use, or hospitalization for any reason within 30 days prior to screening
•Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease [COPD], asthma exacerbations) in the past 6 months prior to screening
•Uncontrolled hypertension, in the opinion of the investigator
•History of heart failure hospitalization, diagnosis of a myocardial infarction, stroke, transient ischemic attack, unstable angina, percutaneous or surgical revascularization procedure (coronary, carotid, or peripheral vascular), or intracardiac device placement (eg, pacemaker) within 12 months prior to screening
•Cancer requiring treatment currently or in the past 5 years, except for non-melanoma skin cancer or cervical/anus in-situ
•Is pregnant at screening
•Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

研究组 & 干预措施

Co-formulated casirivimab+imdevimab SC

Experimental

Randomized 1:1

干预措施: Casirivimab+Imdevimab (Drug)

Co-formulated casirivimab+imdevimab IV

Experimental

Randomized 1:1

干预措施: Casirivimab+Imdevimab (Drug)