To Evaluate the safety, tolerability and pharmacokinetic property after KD101 multiple oral dosing in the fed state in obese or overweight subjects.
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
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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