NCT00627120已完成1 期
A Placebo-Controlled, Ascending Single-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
- 48
- 试验地点
- 1
- 主要终点
- Safety as determined by vital signs, physical examinations, ECGs, clinical laboratory evaluations, and AE reporting.
研究概览
简要总结
To assess the safety and tolerability of a single dose of VGX-1027 in the range of 1-800mg.
详细描述
This study will evaluate:
- The safety and tolerability of a single dose of VGX-1027 as determined by: adverse event reporting, clinical laboratory results, vital signs, physical examinations, and electrocardiograms (ECGs).
- The pharmacokinetic (PK) profile of VGX-1027 maximum concentration (Cmax)
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.
- •Healthy 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 of 18-30kg/m^2 inclusive
- •Males or females ages 18-60, inclusive. Women who are not of childbearing potential may enroll. Women must have a negative pregnancy test within 72 hours prior to start of study drug administration or be surgically sterile.
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 the study and for three months following dosing
- •Any significant acute or chronic mental illness
- •Current or recent 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 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 determinations
- •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 drug within 4 weeks prior to enrollment or greater that 4 weeks for investigational drugs that may have a longer half-life
- •Use of any prescription drugs or 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 3 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 must not be enrolled into this study.
研究组 & 干预措施
1
Experimental
1mg dose group
干预措施: VGX-1027 (Drug)
2
Experimental
10mg dose group
干预措施: VGX-1027 (Drug)
3
Experimental
100mg dose group
干预措施: VGX-1027 (Drug)
4
Experimental
200mg dose group
干预措施: VGX-1027 (Drug)
5
Experimental
400mg dose group
干预措施: VGX-1027 (Drug)
6
Experimental
800mg dose group
干预措施: VGX-1027 (Drug)
结局指标
主要结局
Safety as determined by vital signs, physical examinations, ECGs, clinical laboratory evaluations, and AE reporting.
时间窗: Day 8
次要结局
- Pharmacokinetics(Day 4)
研究者
研究点 (1)
Loading locations...
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