NCT04519437已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 974
- 试验地点
- 1
- 主要终点
- Concentrations of REGN10933 in serum over time
研究概览
简要总结
The primary objectives are:
- To assess the occurrence of adverse events of special interest (AESIs) in participants treated with repeated subcutaneous (SC) doses of REGN10933+REGN10987 compared to placebo
- To assess the concentrations of REGN10933 and REGN10987 in serum over time after single and repeated SC administration
The secondary objectives are:
- To assess the safety and tolerability of repeated SC doses of REGN10933+REGN10987 compared to placebo
- To assess attainment of target concentrations of REGN10933 and REGN10987 in serum after single and repeated SC administration
- To assess the immunogenicity of REGN10933 and REGN10987
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 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 is stable and well controlled as per the opinion of the investigator and is not likely to require medical intervention through the end of study
- •Stable medication for co-morbid condition(s) for at least 6 months prior to screening
- •Willing and able to comply with study visits and study-related procedures, including compliance with site precautionary requirements related to SARS-CoV-2 infection and transmission
排除标准
- •Positive diagnostic test for SARS-CoV-2 infection ≤72 hours prior to randomization
- •Subject-reported clinical history of COVID-19 as determined by investigator
- •Subject-reported history of prior positive diagnostic test for SARS-CoV-2 infection
- •Active respiratory or non-respiratory symptoms suggestive or consistent with COVID-19
- •Medically attended acute illness, systemic antibiotics use, or hospitalization (ie, >24 hours) 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
- •Received investigational or approved SARS-CoV-2 vaccine
- •Received investigational or approved passive antibodies for SARS-CoV-2 infection prophylaxis as defined in the protocol
- •Use of remdesivir, intravenous immunoglobulin (IVIG), or other anti-SARS viral agents within 2 months prior to screening
- •NOTE: Other protocol-defined Inclusion/ Exclusion criteria apply
研究组 & 干预措施
REGN10933+REGN10987
Experimental
干预措施: REGN10933+REGN10987 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Concentrations of REGN10933 in serum over time
时间窗: Up to 52 weeks
Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration
时间窗: Within 4 days postdose at Day 141
Concentrations of REGN10987 in serum over time
时间窗: Up to 52 weeks
次要结局
- Proportion of participants with treatment-emergent adverse events (TEAEs)(Up to 52 weeks)
- Severity of TEAEs(Up to 52 weeks)
- Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933(Up to 52 weeks)
- Proportion of participants who achieve or exceed target concentration in serum of REGN10987(Up to 52 weeks)
- Proportion of participants who achieve or exceed target concentration in serum of REGN10933(Up to 52 weeks)
- Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987(Up to 52 weeks)
研究者
研究点 (1)
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