NCT00760396已完成1 期
A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety and Pharmacokinetics of VGX-1027 in Healthy Subjects
适应症
干预措施
相关药物
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
- Safety as determined by vital signs, ECGs, clinical laboratory evaluations and AE reporting.
研究概览
简要总结
The purpose of this study is to evaluate the safety profile, tolerability and pharmacokinetics following multiple oral doses of 40mg to 200mg VGX 1027 in healthy subjects administered for 5 days.
详细描述
This study will evaluate:
- The safety and tolerability of multiple oral doses of VGX 1027 in the range of 40 to 400mg.
- The pharmacokinetics of VGX 1027 in healthy subjects following the first oral dose (Day 1) and at steady state (Day 5).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must give written informed consent.
- •Healty subjects as determined by no clinically significant deviation from normal as judged by the investigator in medical history, physical examination, ECGs and clinical laboratory evaluations.
- •Body Mass Index (BMI) of 18 to 30kg/m2 ±0.5kg/m2 inclusive.
排除标准
- •Women who are of childbearing potential.
- •Women who are pregnant or breastfeeding.
- •Women with a positive pregnancy test on enrollment or prior to study drug administration.
- •Male subjects who are unwilling to agree to practice barrier contraception during study participation and 3 months following dosing.
- •Any significant acute or chronic medical illness
- •Current or recent (within 3 months) gastrointestinal disease that may impact the absorption of the drug.
- •Any major surgery within 4 weeks of enrollment.
- •Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of enrollment.
- •Blood transfusion within 4 weeks of enrollment.
- •Inability to tolerate oral medication.
- •Inability to be venipunctured and/or tolerate venous access.
- •Recent (within 6 months) drug or alcohol abuse.
- •History of bleeding disorder.
- •History of head trauma or seizures.
- •Any other sound medical, psychiatric and/or social reason as determined by the Investigator.
- •Evidence of organ dysfunction or any clinically significant deviation from normal in vital signs, physical examination, ECG, or clinical laboratory determination.
- •Positive urine screen for drugs of abuse
- •Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, HIV 1/2 antibody
- •History of any significant drug allergy
- •Exposure to any investigational druge within 4 weeks prior to enrollment or greater than 4 weeks for investigational drugs that may have a longer half life.
- •Use of any prescription drugs, over the counter acid controllers within 4 weeks prior to enrollment.
- •Use of any other drugs, including over the counter vitamins, medications and/or herbal preparations within 2 weeks prior to enrollment
- •Use of oral, injectable or implantable hormonal contraceptive agents within three months prior to enrollment
- •Use of alcohol containing beverages within 1 week prior to enrollment
- •Use of grapefruit containing products within 1 week prior to enrollment
- •Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness
研究组 & 干预措施
Group 1
Experimental
40mg QD dose group
干预措施: VGX-1027 (Drug)
Group 2
Experimental
100mg QD dose group
干预措施: VGX-1027 (Drug)
Group 3
Experimental
200mg QD dose group
干预措施: VGX-1027 (Drug)
Group 4
Experimental
200mg BID dose group
干预措施: VGX-1027 (Drug)
结局指标
主要结局
Safety as determined by vital signs, ECGs, clinical laboratory evaluations and AE reporting.
时间窗: Day 8
次要结局
- Pharmacokinetics(Day 8)
研究者
研究点 (1)
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