NCT05293678已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Regeneron Anti-SARS-CoV-2 Monoclonal Antibody/Ies in Adult Healthy 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
- 104
- 试验地点
- 1
- 主要终点
- Occurrence and severity of all serious adverse events (SAEs)
研究概览
简要总结
The primary objective of the study is to evaluate the safety and tolerability of REGN15160 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 REGN15160 in serum
- To assess the immunogenicity of REGN15160
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 a SARS-CoV-2 negative test result from a sample collected ≤72 hours prior to randomization using a local reverse transcription polymerase chain reaction (RT-PCR) test or other molecular diagnostic assay and sample collection following assay standards
- •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, as defined in the protocol
- •Is in good health based on laboratory safety testing obtained at the screening visit
排除标准
- •History of clinically significant disease and any concern, as defined in the protocol and as assessed by the investigator, that may confound the results of the study or poses an additional risk to the participant by study participation
- •Was hospitalized (ie, >24 hours) for any reason within 30 days of the screening visit
- •Has history of alcohol or drug abuse as determined by the investigator
- •Has a history of significant multiple and/or severe allergies (eg, latex gloves), or has had an anaphylactic reaction to prescription or non-prescription drugs or food
- •Use of any prescription and non-prescription 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
- •Participated in any clinical research study evaluating another investigational drug including biologics or therapy, including 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
- •Is a pregnant or breastfeeding woman
- •Is a woman of childbearing potential (WOCBP)1 who is unwilling to practice highly effective contraception (as defined in the protocol) prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after study drug administration
- •NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply
研究组 & 干预措施
Lower IV Dose
Experimental
Randomized 3:1
干预措施: REGN15160 (IV) (Drug)
Lower IV Dose
Experimental
Randomized 3:1
干预措施: Matching Placebo (IV) (Drug)
Mid IV Dose 1
Experimental
Randomized 3:1
干预措施: REGN15160 (IV) (Drug)
Mid IV Dose 1
Experimental
Randomized 3:1
干预措施: Matching Placebo (IV) (Drug)
Mid IV Dose 2
Experimental
Randomized 3:1
干预措施: REGN15160 (IV) (Drug)
Mid IV Dose 2
Experimental
Randomized 3:1
干预措施: Matching Placebo (IV) (Drug)
Higher IV Dose
Experimental
Randomized 3:1
干预措施: REGN15160 (IV) (Drug)
Higher IV Dose
Experimental
Randomized 3:1
干预措施: Matching Placebo (IV) (Drug)
Lower SC Dose
Experimental
Randomized 3:1
干预措施: REGN15160 (SC) (Drug)
Lower SC Dose
Experimental
Randomized 3:1
干预措施: Matching Placebo (SC) (Drug)
Mid SC Dose
Experimental
Randomized 3:1
干预措施: REGN15160 (SC) (Drug)
Mid SC Dose
Experimental
Randomized 3:1
干预措施: Matching Placebo (SC) (Drug)
Higher SC Dose
Experimental
Randomized 3:1
干预措施: REGN15160 (SC) (Drug)
Higher SC Dose
Experimental
Randomized 3:1
干预措施: Matching Placebo (SC) (Drug)
结局指标
主要结局
Occurrence and severity of all serious adverse events (SAEs)
时间窗: Through Day 169
Occurrence and severity of all treatment emergent adverse events (TEAEs)
时间窗: Through Day 169
次要结局
- Incidence and titer of anti-drug antibodies (ADA) to REGN15160(Through Day 169)
- Concentrations of REGN15160 in serum(Through Day 169)
研究者
研究点 (1)
Loading locations...
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