None listed
Conditions
Interventions
Drug : Single Ascending Dose (50 mg, 100 mg, 400 mg, 600 mg, 800 mg)
? Screening (-28d~-2d)
For volunteers, within 4 weeks (-28 days to -2 days) from the scheduled administration date of IP, screening
Sponsors
Cureverse
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Young adults: Healthy Korean or Caucasian volunteers aged 19 to 45 years at the time of screening Elderly: Healthy Korean volunteers aged 65 to 85 years at the time of screening * Caucasian volunteers must be born in Europe, have lived outside of Europe for less than 10 years, and have parents and grandparents who were all born in Europe of full European descent. 2) Individuals with a body weight = 50.0 kg to = 90.0 kg and a Body Mass Index (BMI) = 18.5 kg/m2 to = 29.9 kg/m2 at the time of screening ? Body mass index, kg/m2= weight(kg)/{height(m)}2 3) Individuals who agree to stay exclusively in the clinical trial center ward until discharge and to wear hats and sunglasses and use sunscreen from the time of discharge until the Post-Study Visit (PSV) 4) In the case of all female individuals, individuals who are either naturally postmenopausal (at least 12 consecutive months of spontaneous amenorrhea) or surgically sterile (bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, etc.) 5) Individuals who have given written consent on voluntary decision of participation and agree to adhere to the precautions after being fully informed of and completely understanding this clinical trial 6) Individuals confirmed to be eligible by the investigators based on physical examination, clinical laboratory test and interview, etc.
Exclusion criteria
Exclusion criteria: Inclusion Criteria 1) Young adults: Healthy Korean or Caucasian volunteers aged 19 to 45 years at the time of screening Elderly: Healthy Korean volunteers aged 65 to 85 years at the time of screening * Caucasian volunteers must be born in Europe, have lived outside of Europe for less than 10 years, and have parents and grandparents who were all born in Europe of full European descent. 2) Individuals with a body weight = 50.0 kg to = 90.0 kg and a Body Mass Index (BMI) = 18.5 kg/m2 to = 29.9 kg/m2 at the time of screening ? Body mass index, kg/m2= weight(kg)/{height(m)}2 3) Individuals who agree to stay exclusively in the clinical trial center ward until discharge and to wear hats and sunglasses and use sunscreen from the time of discharge until the Post-Study Visit (PSV) 4) In the case of all female individuals, individuals who are either naturally postmenopausal (at least 12 consecutive months of spontaneous amenorrhea) or surgically sterile (bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, etc.) 5) Individuals who have given written consent on voluntary decision of participation and agree to adhere to the precautions after being fully informed of and completely understanding this clinical trial 6) Individuals confirmed to be eligible by the investigators based on physical examination, clinical laboratory test and interview, etc. Exclusion Criteria 1) Individuals with a clinically significant disease or history in hepatobiliary system (liver disease, viral hepatitis, etc.), renal system (kidney disorders, etc.), nervous system, immune system, respiratory system, digestive system, endocrine system, hemato-oncology disease, cardiovascular system (heart failure, Torsades de Pointes, etc.), urinary system, psychiatric disorder (mood disorders, obsessive-compulsive disorder, etc.), or sexual dysfunction (However, elderly with well-controlled hypertension, hyperlipidemia, arthritis, prostatic hyperplasia (mild), or cataracts (treated with surgery) without medication may be included at the investigator’s discretion.) 2) Individuals with a history of a gastrointestinal disorder (Crohn’s disease, gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, etc.) or surgery (except for simple appendectomy or hernia surgery) that may affect the safety, tolerability, pharmacokinetic and pharmacodynamic assessment of the Investigational Product (IP) 3) Individuals with hypersensitivity to drugs (aspirin, antibiotics, etc.) or a history of clinically significant hypersensitivity 4) Individuals with positive result in the serology test (hepatitis B, hepatitis C and human immunodeficiency virus (HIV) test, syphilis test) 5) Individuals with a history of alcohol or drug abuse, or a positive urine screening for any drug of concern for abuse 6) Individuals who exhibited the following results on vital signs measured at sitting position after resting for more than 3 minutes during screening * Systolic Blood Pressure (SBP) 150 mmHg * Diastolic Blood Pressure (DBP) 100 mmHg 7) Individuals who exhibited QT/QTc > 450 msec (male), QT/QTc > 470 msec (female) or clinically significant abnormal findings in rhythm on electrocardiogram (ECG) during the screening tests 8) Individuals who exhibited any of the following results on the clinical laboratory test during the screening tests including additional tests ? AST (SGOT), ALT (SGPT) > 1.5-fold t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ?Monitoring of adverse events and symptoms ?Physical examination ?Vital signs (systolic/diastolic blood pressure, pulse rate, body temperature) ?12-lead electrocardiogram (ECG) ?Clinical laboratory tests (hematology test, blood chemistry test, blood coagulation test, and urinalysis) ?Neurologic examination | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) Evaluation / Exploratory Pharmacodynamic (PD) Evaluation (Blood and Urine sampling) | — |
Countries
Korea, Republic of
Contacts
Public ContactIn-Jin Jang
Seoul National University Hospital
Outcome results
None listed