A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- To assess safety and tolerability and Pharmacokinetics of Aramchol at single doses ranging between 30 and 900 mg (Part A) and in 30 overweight, mildly hypercholesterolemic, subjects receiving multiple doses (Part B)
研究概览
简要总结
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers.
Primary Objectives:
- To assess and characterize the safety and tolerability of Aramchol in 16 healthy male subjects at single doses ranging between 30 and 900 mg (Part A) and in 30 overweight, mildly hypercholesterolemic, otherwise healthy male subjects receiving multiple doses (Part B)
- To assess the pharmacokinetics of Aramchol at the administered doses
详细描述
Number of Subjects:
Total: A total of 46 healthy subjects will be enrolled. Part A: Sixteen (16) subjects will participate in four, 8-person dosing periods. Each cohort will be alternately dosed twice.
Part B: Thirty (30) subjects will be enrolled in two, 15-person dose-ascending cohorts.
Main Inclusion Criteria:
Part A: Healthy male volunteers aged 18-50 (inclusive) years who have provided written informed consent Part B: Mildly overweight (25<BMI<33), with fasting cholesterol levels of 200-300 mg/% or LDL 100-180 mg/% and triglycerides < 200 mg/%, otherwise healthy male volunteers aged 18-50 (inclusive) years, who have provided written informed consent
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Part A: Healthy male volunteers aged 18-50 (inclusive) years who have provided written informed consent
- •Part B: Mildly overweight (25<BMI <33), with fasting cholesterol levels of 200-300 mg/% or LDL 100-180 mg/% and triglycerides < 200 mg/%, otherwise healthy male volunteers aged 18-50 (inclusive) years, who have provided written informed consent
排除标准
- •History of significant neurological (including history of seizures or EEG abnormalities), renal, cardiovascular (including known structural cardiac abnormalities or hypertension), respiratory (asthma), endocrinological, gastrointestinal, hematopoietic disease, neoplasm, psychological (marked anxiety, tension or agitation) or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medications.
- •History of drug or alcohol abuse.
- •Known allergy to any drug. Known allergy to any drug.
- •Clinically significant abnormalities found in the screening physical exam.
- •Significant abnormalities in clinical laboratory parameters (hematology, biochemistry, urinalysis) determined within 40 days of the start of the study and on Day (-1) before first dosing session. Parameters to be measured are those shown in Appendix 2.
研究组 & 干预措施
Placebo
Placebo control single dose
干预措施: Aramchol (Drug)
Dose 1
Dose 30 mg
干预措施: Aramchol (Drug)
Dose 2
Dose 100 mg
干预措施: Aramchol (Drug)
Dose 3
Dose 300 mg
干预措施: Aramchol (Drug)
Dose 4
Dose 900 mg
干预措施: Aramchol (Drug)
Dose 1 repeated
Dose 30 mg for 4 days
干预措施: Aramchol (Drug)
Dose 2 repeated
Dose high for 4 days
干预措施: Aramchol (Drug)
结局指标
主要结局
To assess safety and tolerability and Pharmacokinetics of Aramchol at single doses ranging between 30 and 900 mg (Part A) and in 30 overweight, mildly hypercholesterolemic, subjects receiving multiple doses (Part B)
时间窗: day 1 to 6
次要结局
- To assess and characterize the drug effect on lipid profile and functional pharmacodynamics following single and multiple dose administrations.(day 1 to 6)