A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN3500 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The incidence and severity of treatment-emergent adverse events in subjects treated with REGN3500
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN3500 in healthy adult males and females
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Body Mass Index</= 33 kg/m2
- •In good health based on medical history, physical examination, vital signs, and laboratory testing
- •Normal electrocardiogram (ECG) and blood pressure
- •Able to comply with clinic visits and study-related procedures
- •Able to sign an informed consent
排除标准
- •Significant abnormalities in hematology, clinical chemistry, urinalysis, medical history
- •Current smoker or recent history (within 3 months)
- •History of tuberculosis, HIV, or hepatic disease
- •Known sensitivity to doxycycline or other ingredients of study drug
- •History of multiple/severe allergies
- •Pregnant or breastfeeding women, or not currently using adequate contraception
- •Participation in another investigational drug study within 4 weeks
研究组 & 干预措施
Cohort 4
Dose regimen 4 of REGN3500 (SC) versus placebo
干预措施: Placebo (Drug)
Cohort 5
Dose regimen 5 of REGN3500 (IV) versus placebo
干预措施: REGN3500 (Drug)
Cohort 5
Dose regimen 5 of REGN3500 (IV) versus placebo
干预措施: Placebo (Drug)
Cohort 1
Dose regimen 1 of REGN3500 (IV) versus placebo
干预措施: REGN3500 (Drug)
Cohort 1
Dose regimen 1 of REGN3500 (IV) versus placebo
干预措施: Placebo (Drug)
Cohort 2
Dose regimen 2 of REGN3500 (IV) versus placebo
干预措施: REGN3500 (Drug)
Cohort 2
Dose regimen 2 of REGN3500 (IV) versus placebo
干预措施: Placebo (Drug)
Cohort 3
Dose regimen 3 of REGN3500 (IV) versus placebo
干预措施: REGN3500 (Drug)
Cohort 3
Dose regimen 3 of REGN3500 (IV) versus placebo
干预措施: Placebo (Drug)
Cohort 4
Dose regimen 4 of REGN3500 (SC) versus placebo
干预措施: REGN3500 (Drug)
结局指标
主要结局
The incidence and severity of treatment-emergent adverse events in subjects treated with REGN3500
时间窗: Up to 293 days after dosing
次要结局
- Obtain the pharmacokinetic parameters (Cmax) that describe the serum concentration time profile of REGN3500(Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing)
- Obtain the pharmacokinetic parameters (Tmax) that describe the serum concentration time profile of REGN3500(Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing)
- Obtain the pharmacokinetic parameters (AUClast) that describe the serum concentration time profile of REGN3500(Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing)