NCT01235871已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SB1578 When Administered Orally to Healthy Adult Subjects With One Single-Dose Group Crossing Over to Assess Food Effect
S*BIO1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assess number of participants with adverse events as a measure of safety and tolerability
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of SB1578 in healthy 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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males and/or females of non-childbearing potential, 18 to 55 years of age (inclusive).
- •Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55 and 100 kg (inclusive).
- •Medically healthy with clinically insignificant screening results.
排除标准
- •History or presence of significant disease.
研究组 & 干预措施
SB1578
Experimental
干预措施: SB1578 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Assess number of participants with adverse events as a measure of safety and tolerability
时间窗: 312 hours postdose
次要结局
- Assess pharmacokinetics to determine study drug half-life, maximum concentration time, elimination time, and area under the curve(Predose to 312 hours postdose)
- Assess pharmacodynamics to determine study drug levels to signal pJAK2, pSTAT3, and pSTAT5(Predose, 6 and 24 hours postdose)
- Assess food effects on pharmacokinetics(Predose to 312 hours postdose)
- Determine recommended dose(March 2011)
研究者
研究点 (1)
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