NCT01540539已完成1 期
Intravenous/Subcutaneous FIH Study of REGN1154 in 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
- 44
- 主要终点
- Total number and severity of TEAEs
研究概览
简要总结
The purpose of this study is to study the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of REGN1154 in normal healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Healthy men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile
- •Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive
- •Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures
- •Able to read or to understand the consent process, and willing to sign the informed consent form (ICF)
排除标准
- •Exclusion criteria include, but are not limited to the following:
- •Any illness or condition that would adversely affect the subject's participation in this study
- •Any clinically significant abnormalities observed during the screening visit
- •Use of certain medications taken before the screening visit
- •Onset of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit
- •Hospitalization within 60 days of the screening visit
- •Any condition that would place the subject at risk, interfere with participation in the study
- •History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
- •History of certain other conditions
- •Positive urine, drug or alcohol screen result at screening
- •Known sensitivity to any of the components of the investigational product formulation
- •Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit
- •Live/attenuated vaccinations within 12 weeks of screening or during the study
研究组 & 干预措施
Dosing cohort 7
Experimental
干预措施: REGN1154 or placebo (Drug)
Dosing cohort 8
Experimental
干预措施: REGN1154 or placebo (Drug)
Dosing cohort 5
Experimental
干预措施: REGN1154 or placebo (Drug)
Dosing cohort 6
Experimental
干预措施: REGN1154 or placebo (Drug)
Dosing cohort 1
Experimental
干预措施: REGN1154 or placebo (Drug)
Dosing cohort 2
Experimental
干预措施: REGN1154 or placebo (Drug)
Dosing cohort 3
Experimental
干预措施: REGN1154 or placebo (Drug)
Dosing cohort 4
Experimental
干预措施: REGN1154 or placebo (Drug)
结局指标
主要结局
Total number and severity of TEAEs
时间窗: Day 1 through Day 113
TEAEs (Treatment-emergent adverse events)
次要结局
- Serum concentration(Day 1 through Day 113)
- Presence or absence of antibodies(Day 1 through Day 113)
研究者
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