NCT01367873已完成1 期
A Randomized, Double-blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196 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
- 72
- 试验地点
- 1
- 主要终点
- Number of Adverse Events as a measure of safety and tolerability of VIA-3196
研究概览
简要总结
This is a single-center, randomized, double-blind, placebo-controlled, ascending single-dose study of VIA-3196 to evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196 in Healthy Subjects. Study dosing is organized into cohorts corresponding to escalating doses of VIA-3196 or matching placebo.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject must be willing and able to provide written informed consent.
- •Healthy, non-smoking, males and females between the ages of 18 and 55 years of age (inclusive).
- •If female, the subject is of non-child bearing potential (i.e., surgically [bilateral oophorectomy, hysterectomy, or tubal ligation] or naturally sterile [>12 consecutive months without menses]). Verify by FSH at screening as appropriate.
- •Body weight > 50 kg and BMI between 18 and 30 kg/m2 (inclusive).
- •LDL cholesterol > 85 mg/dL.
- •No clinically significant abnormal findings on blood pressure, heart rate, physical examination, clinical laboratory tests or 12-lead ECG.
排除标准
- •History of thyroid disorder or abnormal thyroid function tests at screening. Repeat testing is allowed at the discretion of the Investigator.
- •History of unexplained syncope.
- •History of hepatobiliary disease; or AST, ALT or direct bilirubin greater than the upper limit of reference range at screening.
- •Positive screening test for HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody.
- •Abnormal screening ECG: including machine-read QTc >450 msec, QRS >110 msec, intermittent bundle branch block, frequent premature atrial or premature ventricular contractions, or any rhythm other than normal sinus rhythm which is interpreted by the Investigator to be clinically significant.
- •History of sensitivity to a similar study drug (e.g., Karo Bio KB2115 or Metabasis MB7811), or a history of important drug or other allergy (except for untreated, asymptomatic seasonal allergies at time of dosing).
- •Sensitivity to thyroid medication.
- •History of asthma, or intolerance to beta-blockers.
- •Use of acetaminophen within 7 days before dosing and throughout the study.
- •History of regular use of tobacco or nicotine containing products within the past 6 months.
- •Positive urine drug screen or alcohol test at screening.
研究组 & 干预措施
VIA-3196
Experimental
Multiple, single-dose, ascending dosing groups (cohorts) will be evaluated.
干预措施: VIA-3196 (Drug)
Placebo
Placebo Comparator
Multiple, single-dose, ascending dosing groups (cohorts) will be evaluated.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Adverse Events as a measure of safety and tolerability of VIA-3196
时间窗: up to 12 days
Evaluation will start from predose (Day -1) until the follow-up visit (Day 7 to 11)
次要结局
- Plasma concentration of VIA-3196(0 to 72 hours)
研究者
研究点 (1)
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