To Evaluate the Safety, Tolerability, PK, PK-PD Relation of KD101 in the Fed State in Obese or Overweight Subjects

Kwang Dong Pharmaceutical

Status and phase

Unknown

Phase 1

Conditions

Obesity

Treatments

Drug: KD101

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02462031

KD101-102

Details and patient eligibility

About

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

Full description

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

Enrollment

38 estimated patients

Sex

All

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

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