NCT03643627已完成早期 1 期
A Phase 1a, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study of SYNT001 in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- assessment of safety data (counts and percentages of adverse events)
研究概览
简要总结
This study is being done to compare the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of an intravenous (IV) formulation of SYNT001. This is the first-in-human (FIH) study of SYNT001.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects must meet the following criteria to be included:
- •Healthy as determined by comprehensive clinical assessment and clinical laboratory investigations
- •Body mass index 18.5 to 30.0 kg/m2
- •Must use medically acceptable contraception
- •Willingness to complete all study measurements and assessments in compliance with the protocol
排除标准
- •Subjects meeting any of the following criteria are to be excluded:
- •Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety or affect the PK evaluations
- •Subject unable or unwilling to comply with the protocol
- •Any exposure to an investigational drug within the 30 days prior to screening
- •Use of any tobacco or nicotine-containing products
- •Abuse of alcohol
- •Positive drug test or history of drug abuse
研究组 & 干预措施
10 mg/kg
Experimental
干预措施: SYNT001 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
1 mg/kg
Experimental
干预措施: SYNT001 (Drug)
3 mg/kg
Experimental
干预措施: SYNT001 (Drug)
30 mg/kg
Experimental
干预措施: SYNT001 (Drug)
结局指标
主要结局
assessment of safety data (counts and percentages of adverse events)
时间窗: Day 0 - Day 28
counts and percentages of adverse events
次要结局
- Pharmacokinetics (serum concentration of SYNT001)(Pre-dose and 0.08, 2, 4, 6, 8, 12, 16, 20, 24, 48, 72, and 120 hours post dose)
- Pharmacodynamics(Days 1 (pre dose), 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 21 and 28)
研究者
研究点 (1)
Loading locations...
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