None listed
Conditions
Interventions
Drug : In the single dose study, KDS2010 is administered to healthy young adults in 30, 60, 120, 240, 480, and 960 mg doses once, and a placebo control group of the same dose for each dose group is es
Sponsors
NeuroBiogen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Young subjects: Healthy Korean or Caucasian volunteers between 19 and 45 years of age at the screening visit Elderly subjects: Healthy Korean volunteers over 65 years and under 85 years of age at the screening visit ? Caucasian who were born in Europe, have lived outside Europe for less than 10 years, and both parents and grandparents were of European origin 2) Women: Except for surgical infertility (bilateral fallopian tube occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, etc.), those who tested negative in the urine pregnancy test (hCG) performed at screening 3) Subjects with body weight between 55.0 kg and 90.0 kg and Body Mass Index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the screening visit ? Body Mass Index = body weight(kg)/ [height(m)]2 4) Subjects who completely understand the nature of study and make a voluntary decision to participate in this clinical study and provide the informed consent. 5) Subjects who are considered to be suitable to participate in this study based on physical examination, clinical laboratory test results and medical history
Exclusion criteria
Exclusion criteria: 1) Subjects with a clinical evidence or history of hepatic, renal, neurologic, immunologic, respiratory, endocrine, hematologic, oncologic, cardiovascular, psychiatric disease (However, in the case of an elderly person with a history of mild disease, participation is possible if the researcher determines that the drug can be discontinued at least 2 weeks before the expected first dose or 5 times or more before the half-life.) 2) Subjects with a history of gastrointestinal disease (e.g., gastrointestinal ulcers, gastritis, stomach cramp, gastroesophageal reflux disease, Crohn’s disease, etc.) or surgery (except for simple appendectomy or herniotomy), which can influence the safety and pharmacokinetic evaluation of investigational drugs 3) For all women of childbearing age, except for surgical infertility, those who are pregnant, may be pregnant, or are lactating 4) Subjects with clinically significant abnormalities in the neurological examination performed at the screening visit 5) Subjects with any of the following vital signs at the screening visit ? Systolic blood pressure (SBP): 140 mmHg ? Diastolic blood pressure (DBP): 90 mmHg ? Heart rate: 90 bpm 6) Subjects with any of the following clinical laboratory test results at the screening visit ? AST, ALT: > upper normal limit × 1.5 ? Total bilirubin: > upper normal limit × 1.5 ? CPK: > upper normal limit × 1.5 ? Creatinine clearance calculated by CKD-EPI equation: 210 msec ? QRS complex > 120 msec ? QTcB > 450 msec ? Other, clinically significant arrhythmias 8) Subjects with a history of hypersensitivities including drug allergies (caused by aspirin, antibiotics, etc.), or a history of clinically significant hypersensitivities 9) Subjects with a history of alcohol or drug abuse, or with positive reaction to any drug of concern for abuse/misuse at the urine drug screening test 10) Subjects who had taken or are expected to take any prescription drug or herbal medicine within 2 weeks or any over the counter (OTC) drug within 1 week prior to the first administration day (however, subjects fulfilling other conditions could participate in the study at the investigator’s discretion) 11) Subjects who had taken an inducer or inhibitor of drug metabolism such as barbiturates etc. within 1 month prior to the first administration day 12) Subjects who had participated in another clinical study (including bioequivalence studies) within 6 months prior to the first administration day 13) Subjects who had donated whole blood or component blood, or received transfusion within 3 months prior to the first administration day 14) Subjects who drink continuously (more than 21 units/week, 1 unit = 10 g of pure alcohol) or are unable to stop drinking during the period from 3 days prior to the first administration day to the end of the study 15) Smokers (except for whom quitted smoking prior to the first administration day for at least 3months) or who cannot stop smoking during the period from 3 months prior to the first administration day to the end of the study 16) Subjects who cannot stop taking grapefruit or food containing grapefruit during the period from 3 days prior to the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety & tolerability;pharmacokinetics | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacodynamics | — |
Countries
Korea, Republic of
Contacts
Public ContactJiyeon Park
Seoul National University Hospital
Outcome results
None listed