NCT03641794Unknown1 期
A Phase I Study of DN1406131 in Healthy Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- adverse events - type, incidence, severity
研究概览
简要总结
This is a double blind Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of DN1406131, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and tryptophan 2,3-Dioxygenase 2 (TDO-2) and help the human immune system attack solid tumor cells more effectively.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age greater of 18 years and less than 45
- •Weight ≥50 kg,body mass index of 19~26 kg/m2
- •Signed ICF
排除标准
- •active autoimmune disease
- •uncontrolled concurrent illness
- •positive serology for HIV, Hepatitis B or C,Syphilis
- •Pregnancy or breastfeeding
研究组 & 干预措施
DN1406131
Experimental
25 mg,50 mg,100 mg,200 mg,400 mg,600 mg,800 mg
干预措施: DN1406131 (Drug)
Placebo
Placebo Comparator
25 mg,50 mg,100 mg,200 mg,400 mg,600 mg,800 mg
干预措施: Placebo (Drug)
结局指标
主要结局
adverse events - type, incidence, severity
时间窗: 28 day
Evaluate the safety and toxicity of DN1406131 in healthy volunteers
Maximum Tolerated Dose
时间窗: 14 day
To define the Maximum Tolerated Dose (MTD)
次要结局
- Peak Plasma Concentration (Cmax)(48 hours)
- Serum for biomarkers of IDO activity (kynurenine and tryptophan)(48 hours)
- Elimination half-life(48 hours)
- peak time(48 hours)
研究者
研究点 (1)
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