Study to Assess the Safety and Tolerability of Ascending Single Doses of REGN2009 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 主要终点
- Number of TEAEs
研究概览
简要总结
This is a phase 1, randomized, double-blind, placebo-controlled first-in-human (FIH) study to assess the safety and tolerability of ascending single doses of REGN2009 administered to healthy volunteers.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women ages 18 to 65 years inclusive
- •Body mass index between 18.0 kg/m^2 and 30.0 kg/m^2, inclusive
排除标准
- •Pregnant or breast-feeding women
- •Any clinically significant abnormalities observed during screening (day -21 to day -2)
- •Known history of human immunodeficiency virus (HIV) antibody; and/or positive hepatitis B surface antigen, and/or positive hepatitis C antibody at the screening visit
- •History of drug or alcohol abuse within a year prior to the screening visit (day -21 to day -2)
- •Hospitalization for any reason within 60 days of the screening visit (day -21 to day -2)
- •Participation in any clinical research study within 30 days of the screening visit (day -21 to day -2) or within 5 half-lives of the investigational drug or therapy being studied (whichever is longer)
- •History of a hypersensitivity reaction to doxycycline or similar compound
- •Any medical or psychiatric condition which, in the opinion of the investigator, would place the subject at risk, interfere with participation in the study or interfere with the interpretation of the study results
- •Previous adverse experience to any biological investigational or therapeutic agent
- •Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study
- •The above information 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
REGN2009 dose level 1
Cohort A - REGN2009 or placebo; Cohort B - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)
干预措施: REGN2009 (Drug)
REGN2009 dose level 1
Cohort A - REGN2009 or placebo; Cohort B - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)
干预措施: placebo (Other)
REGN2009 dose level 2
Cohort C - REGN2009 or placebo; Cohort D - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)
干预措施: REGN2009 (Drug)
REGN2009 dose level 2
Cohort C - REGN2009 or placebo; Cohort D - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)
干预措施: placebo (Other)
REGN2009 dose level 3
Cohort E - REGN2009 or placebo; Cohort F - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)
干预措施: REGN2009 (Drug)
REGN2009 dose level 3
Cohort E - REGN2009 or placebo; Cohort F - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)
干预措施: placebo (Other)
结局指标
主要结局
Number of TEAEs
时间窗: day 1 to day 106/ visit 15
The primary endpoint in this study is the incidence and severity of Treatment Emergent Adverse Events (TEAEs) in healthy volunteers treated with REGN2009 or placebo reported from day 1 (baseline) to the completion of the study on day 106/ visit 15.
次要结局
未报告次要终点