NCT01922661已完成1 期
Single Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Subjects
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
- 24
- 主要终点
- Safety
研究概览
简要总结
The primary objective of the study is to assess the safety and tolerability of single ascending doses of subcutaneously (SC) administered REGN1908-1909 in allergic, adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy men and women between the ages of 18 and 55
- •Positive allergen skin prick test
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide signed informed consent
排除标准
- •Persistent, chronic, or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit
- •Any clinically significant (determined at the investigator's discretion) abnormalities observed during the screening physical examination
- •Onset of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to the screening visit. Patients must be willing to maintain a similar level of exercise for the duration of the study and to refrain from unusually strenuous exercise for the duration of the trial
- •Hospitalization for any reason within 60 days prior to the screening visit
- •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
- •Any medical or psychiatric condition that in the opinion of the investigator or Regeneron, would place the patient at risk, interfere with participation in the study or interfere with the interpretation of study results
- •The information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.
研究组 & 干预措施
Cohort 1
Experimental
Dose 1 of REGN1908-1909 or placebo
干预措施: REGN1908-1909 (Drug)
Cohort 1
Experimental
Dose 1 of REGN1908-1909 or placebo
干预措施: placebo (Other)
Cohort 2
Experimental
Dose 2 of REGN1908-1909 or placebo
干预措施: REGN1908-1909 (Drug)
Cohort 2
Experimental
Dose 2 of REGN1908-1909 or placebo
干预措施: placebo (Other)
Cohort 3
Experimental
Dose 3 of REGN1908-1909 or placebo
干预措施: REGN1908-1909 (Drug)
Cohort 3
Experimental
Dose 3 of REGN1908-1909 or placebo
干预措施: placebo (Other)
结局指标
主要结局
Safety
时间窗: day 1 to day 113
The primary endpoint is to assess treatment-emergent adverse events (TEAEs) from day 1 through day 113 (end of study).
次要结局
- Serum concentration(day 1 to day 113)
研究者
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