NCT02741739已完成1 期
A Randomized, Open-Label, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of REGN1033 Produced From Two Different Cell Lines in Healthy 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
- 28
- 主要终点
- Serum REGN1033 concentration-time curve (AUC)
研究概览
简要总结
Primary Objective: Determine blood concentrations of two formulations of REGN1033.
Secondary Objective: Assess safety and tolerability of REGN1033.
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
- None
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 males and females (not of childbearing potential) between the ages of 18 and 65 years
- •Body weight between 50.0 kg and 95.0 kg
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide signed informed consent
排除标准
- •Donation or loss of approximately 400 mL or more of blood within 8 weeks prior to dosing, or plasma up to 14 days prior to dosing
- •Hemoglobin not within normal limits
- •Positive drug and alcohol screen test results at screening visits 1 and 2
- •Low or elevated blood pressure and/or heart rate after 3 minutes resting in the seated position:
- •Recent use (within 3 months prior to screening) of androgenic steroids
- •Participation in any clinical research study that evaluated 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
- •Previous exposure to any biological therapeutic agent, except vaccines
- •Known sensitivity to tamoxifen, doxycycline, or similar compounds (ie, tetracyclines)
- •Pregnant or breastfeeding women, and women of childbearing potential
- •Sexually active men who are unwilling to practice adequate contraception during the study
研究组 & 干预措施
Reference Drug
Experimental
REGN1033 Reference Formulation
干预措施: REGN1033 (Drug)
Test Drug
Experimental
REGN1033 Test Formulation
干预措施: REGN1033 (Drug)
结局指标
主要结局
Serum REGN1033 concentration-time curve (AUC)
时间窗: Pre-dose to day 57
Peak REGN1033 concentration (Cmax)
时间窗: Pre-dose to day 57
次要结局
- Treatment-emergent adverse events (TEAEs) from baseline to the end of the study(Day 1 to end of study (Day 57))
- Presence or absence of anti-drug antibody (ADA)(Day 1 to end of study (Day 57))
研究者
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