NCT02462031Unknown1 期
A Randomized, Double-blind, Placebo-controlled, Single or Multiple Ascending Dose Phase I Clinical Trial to Evaluate the Safety, Tolerability, PK, PK-PD Relation of KD101 in the Fed State in Obese or Overweight Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters - Cmax
研究概览
简要总结
To Evaluate the safety, tolerability and pharmacokinetic property after KD101 multiple oral dosing in the fed state in obese or overweight subjects.
详细描述
dose block-randomized, double-blinded, placebo controlled, single or multiple ascending dose study. AEs, PE, Vital signs, ECGs and Clinical lab tests
- Part I : multiple dose study (KD101 or placebo) / male and female
- Part II : single dose study (KD101) / male only
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female adults aged 20 to 55 at screening (Part II : Male adults aged 20 to 55 at screening)
- •Healthy volunteer whose BMI ≥ 27 (Part II : Healthy volunteer whose BMI ≥ 18)
- •Female who are not pregnancy possibility or Male/Female who can abstinence or contraception during clinical trials
排除标准
- •Subjects who had clinically significant disease history (liver,kidney,nervous,pulmonary,endocrinal,urinary,cardiovascular,musculoskeletal,mental system,blood,tumor) or diagnosed within 1 month from screening
- •Subjects who had gastrointestinal disease(Crohn's disease, ulcer, acute/chronic pancreatitis) that affect the absorption of test drug or gastrointestinal operation (However, appendectomy, herniotomy induced by acute appendicitis are excluded)
- •Subjects who had following history. [myocardial infarction (diagnosed by cardiac enzyme and/or diagnostic ECG), cerebral infarction/stroke, arrhythmia needed to medical treatment, unstable angina, pulmonary hypertension]
- •Subjects who had positive result to Human Immunodeficiency Virus, Hepatitis B virus, Hepatitis C virus during screening
- •Subjects who had allergy history (ex. allergy for aspirin, antibiotics, etc) or had clinically-significant allergy
- •Subjects whose systolic BP was <85mmHg or >145mmHg, or diastolic BP was <50mmHg or >95mmHg, or pulse was >100/min after 3 minute-seating position. (BP can be re-measured twice at leat 5 minute-interval)
- •Subjects who would take prescribed/oriental drug(within 2 weeks from the first dosing day) or OTC drug or vitamines (within 1 weeks from the first dosing day)
- •Subjects who drink over than 21 unit (1 unit = 10g of pure alcohol) or cannot quit drinking alcohol during clinical trial period
- •Subjects who ate following food within 2 days from the first dosing day or cannot quit following food [grapefruit-contain food, caffein-contain food(coffee, green tea, black tea, soft drink, coffee milk, energy drink)]
- •Subjects who didn't agree contraception
- •Subjects who didn't agree to quit smoke
- •Subjects who donated his/her blood within 2 months (whole blood) / 1 month (apheresis) or who took transfusion within 1 month
- •Subjects who participated another clinical trials within 3 months from first dosing day. (The clinical trial completion day is defined as the last dosing day of past clinical trial)
- •Subjects who are not adequate to this trial by lab examination and another reasons
- •Subjects who weighed loss more than 5kg in 3 months
研究组 & 干预措施
KD101 placebo
Placebo Comparator
干预措施: placebo (Drug)
KD101
Experimental
干预措施: KD101 (Drug)
结局指标
主要结局
Pharmacokinetic parameters - Cmax
时间窗: up to 4 weeks
Cmax (Maximum concentration of drug in plasma)
次要结局
- Pharmacodynamic parameters - PBMCs(up to 4 weeks)
研究者
研究点 (1)
Loading locations...
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