NCT02777151已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenously Administered REGN3470-3471-3479 in Healthy 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
- Incidence and severity of TEAEs through the end of the study visit in subjects treated with REGN3470-3471-3479 in a fixed dose combination
研究概览
简要总结
This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study evaluating the safety, tolerability, pharmacokinetics (PK) and immunogenicity of REGN3470-3471-3479 in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, 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
- •Healthy man or woman between the ages of 18 and 60
- •Body mass index (BMI) between 18 and 30 kg/m2, inclusive
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide signed informed consent
- •Able to understand and complete study-related questionnaires
排除标准
- •Use of any medications started within 30 days prior to the screening visit including, prescription medications, nutritional supplements, and over-the-counter medications except for vitamin supplements, and recommended doses of acetaminophen, aspirin or ibuprofen
- •Hospitalization for any reason within 60 days prior to the screening visit
- •History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
- •History of or positive blood test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) or hepatitis C virus (HCV) antibody at the screening visit
- •History of drug or alcohol abuse within 1 year prior to screening
- •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 history of receiving treatment, vaccine or mAbs against the Ebola virus
- •Pregnant or breast-feeding women
- •Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).
- •Contraception is not required for men with documented vasectomy.
- •Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of childbearing potential. A baseline follicle-stimulating hormone (FSH) test will be performed for confirmation of menopausal status. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
研究组 & 干预措施
Cohort 1
Experimental
REGN3470-3471-3479 dosing level 1 or placebo
干预措施: REGN3470-3471-3479 (Drug)
Cohort 1
Experimental
REGN3470-3471-3479 dosing level 1 or placebo
干预措施: Placebo (Drug)
Cohort 2
Experimental
REGN3470-3471-3479 dosing level 2 or placebo
干预措施: REGN3470-3471-3479 (Drug)
Cohort 2
Experimental
REGN3470-3471-3479 dosing level 2 or placebo
干预措施: Placebo (Drug)
Cohort 3
Experimental
REGN3470-3471-3479 dosing level 3 or placebo
干预措施: REGN3470-3471-3479 (Drug)
Cohort 3
Experimental
REGN3470-3471-3479 dosing level 3 or placebo
干预措施: Placebo (Drug)
Cohort 4
Experimental
REGN3470-3471-3479 dosing level 4 or placebo
干预措施: REGN3470-3471-3479 (Drug)
Cohort 4
Experimental
REGN3470-3471-3479 dosing level 4 or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and severity of TEAEs through the end of the study visit in subjects treated with REGN3470-3471-3479 in a fixed dose combination
时间窗: From baseline up to day 169
次要结局
- Concentration of REGN3470 in serum over time(From baseline up to day 169)
- Concentration of REGN3479 in serum over time(From baseline up to day 169)
- Concentration of REGN3471 in serum over time(From baseline up to day 169)
- The presence or absence of antibodies against REGN3470 over time(From baseline up to day 169)
- The presence or absence of antibodies against REGN3471 over time(From baseline up to day 169)
- The presence or absence of antibodies against REGN3479 over time(From baseline up to day 169)
研究者
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