A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN17092, an Anti-SARS-CoV-2 (COVID-19) Monoclonal Antibody, in Adult Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Occurrence of all treatment emergent adverse events (TEAEs)
研究概览
简要总结
The purpose of this study is to learn about the safety and tolerability of different doses of REGN17092 administered with a needle either under the skin (called "subcutaneous") or into a vein (called an "infusion") in healthy participants. This is the first time that REGN17092 will be given to people.
Other aims are to assess:
- How much of the study drug is in the blood at different times
- Whether the body makes its own antibodies against the study drug (which could make the drug less effective or 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 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 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/m^2 (inclusive) at the screening visit
- •Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiogram (ECG)s performed at screening and/or prior to administration of initial dose 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 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
- •NOTE: Other protocol defined inclusion / exclusion criteria apply
研究组 & 干预措施
Expansion Cohort 1
Randomized 3:1 for single ascending dose
干预措施: REGN17092 (Drug)
Cohort 1 Mid IV Dose
Randomized 6:2 for single ascending dose
干预措施: REGN17092 (Drug)
Cohort 1 Mid IV Dose
Randomized 6:2 for single ascending dose
干预措施: Matching Placebo (Drug)
Cohort 3 High IV Dose
Randomized 6:2 for single ascending dose
干预措施: REGN17092 (Drug)
Cohort 3 High IV Dose
Randomized 6:2 for single ascending dose
干预措施: Matching Placebo (Drug)
Cohort 5 Higher IV Dose
Randomized 6:2 for single ascending dose
干预措施: REGN17092 (Drug)
Expansion Cohort 1
Randomized 3:1 for single ascending dose
干预措施: Matching Placebo (Drug)
Cohort 5 Higher IV Dose
Randomized 6:2 for single ascending dose
干预措施: Matching Placebo (Drug)
Cohort 6 Low IV Dose
Randomized 6:2 for single ascending dose
干预措施: REGN17092 (Drug)
Cohort 6 Low IV Dose
Randomized 6:2 for single ascending dose
干预措施: Matching Placebo (Drug)
Cohort 2 Mid SC Dose
Randomized 6:2 for single ascending dose
干预措施: REGN17092 (Drug)
Expansion Cohort 2
Randomized 3:1 for single ascending dose
干预措施: REGN17092 (Drug)
Cohort 2 Mid SC Dose
Randomized 6:2 for single ascending dose
干预措施: Matching Placebo (Drug)
Cohort 4 High SC Dose
Randomized 6:2 for single ascending dose
干预措施: REGN17092 (Drug)
Cohort 4 High SC Dose
Randomized 6:2 for single ascending dose
干预措施: Matching Placebo (Drug)
Cohort 7 Low SC Dose
Randomized 6:2 for single ascending dose
干预措施: REGN17092 (Drug)
Cohort 7 Low SC Dose
Randomized 6:2 for single ascending dose
干预措施: Matching Placebo (Drug)
Expansion Cohort 2
Randomized 3:1 for single ascending dose
干预措施: Matching Placebo (Drug)
Expansion Cohort 3
Randomized 3:1 for single ascending dose
干预措施: REGN17092 (Drug)
Expansion Cohort 3
Randomized 3:1 for single ascending dose
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Occurrence of all treatment emergent adverse events (TEAEs)
时间窗: Through approximately day 365
Severity of all TEAEs
时间窗: Through approximately day 365
Occurrence of all treatment emergent serious adverse events (TE-SAEs)
时间窗: Through approximately day 365
Severity of all TE-SAEs
时间窗: Through approximately day 365
次要结局
- Concentrations of REGN17092 in serum over time(Through approximately day 365)
- Incidence of Anti-drug antibodies (ADAs) to REGN17092 over time(Through approximately day 365)
- Titer of ADAs to REGN17092 over time(Through approximately day 365)