NCT00547014已完成1 期
Oral Administration Of CPG 52364 In Healthy Subjects: A Phase 1, Within-Cohort Randomized, Double-Blinded, Placebo-Controlled, Ascending Single-Dose, Single-Center Study
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
- Pfizer
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Clinical Assessment of Adverse Events
研究概览
简要总结
Determine the safety and tolerability of the study drug, CPG 52364, when given as liquid or capsule. Another purpose is to determine how the drug enters and leaves the blood stream and body tissues over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, 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
- •Normal body mass index and weight
- •No significant diseases in the medical history or clinically significant findings on physical exam, opthalmologic exam, clinical laboratory evaluations or 12-lead electrocardiogram
排除标准
- •Current illness or history of medical condition affecting the body's function
- •Use of any medication within 7 days, any immunosuppressive medication within 6 months, any investigational drug within 30 days or any vaccine or immunoglobulin within 90 days
- •Use of any medications during the study
- •Positive TB test
- •Smoking within 6 months
- •Pregnancy or risk of Pregnancy
- •Alcohol or drug misuse within 60 days
- •Sensitivity to quinazolines
研究组 & 干预措施
Cohort 4
Experimental
干预措施: 52364 30 mg (Drug)
Cohort 5
Experimental
干预措施: 52364 100 mg (Drug)
Cohort 1 1mg
Experimental
干预措施: 52364 1 mg (Drug)
Cohort 2
Experimental
干预措施: 52364 3 mg (Drug)
Cohort 3
Experimental
干预措施: 52364 10 mg (Drug)
结局指标
主要结局
Clinical Assessment of Adverse Events
时间窗: 28 days/subject
次要结局
- Pharmacokinetic Parameters(28 days/subject)
研究者
研究点 (1)
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