None listed
Conditions
Interventions
Drug : ATB2005A or its placebo (25 mg or 100 mg oral capsules, one-time oral administration)
Cohort A (25 mg)
Cohort B (50 mg)
Cohort C (100 mg, food effect)
Cohort D (200 mg)
Cohort E (400 mg)
Cohort
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: ? Inclusion criteria 1. Healthy adult males between the ages of 19 and 50 are eligible for participation based on the date of written consent. 2. Individuals with a body weight of 55.0 kg or higher and a body mass index (BMI) ranging from 18.0 kg/m2 to less than 30.0 kg/m2 at the time of screening are eligible. ? BMI (kg/m^2) = Body weight (kg) / {Height(m)}^2 3. Those who participate voluntarily after receiving detailed explanations about this clinical trial, fully comprehending it, and providing written consent before the screening procedure are eligible. 4. Individuals are suitable for this trial by the investigators based on physical examinations, clinical laboratory tests, medical history, and other relevant screenings.
Exclusion criteria
Exclusion criteria: ? Exclusion criteria 1. Individuals with clinically significant diseases or a history of disorders related to the liver, kidney, nervous system, respiratory system, immune system, endocrine system, blood and tumors, cardiovascular system, urinary system, or mental health are not eligible for this trial. 2. Individuals with gastrointestinal disorders (such as gastric ulcers, gastritis, gastric spasms, gastroesophageal reflux disease, Crohn's disease, etc.) that could potentially affect the safety and pharmacokinetic evaluation of the investigational drug or a history of such disorders, as well as those with a history of gastrointestinal surgeries (excluding simple appendectomy and hernia repair) are not eligible for this clinical trial. 3. Individuals currently with lactose intolerance or a history of lactose intolerance 4. Those with a history of hypersensitivity or clinically significant hypersensitivity to investigational drug components (ATB2005A, ATB2005) and other drugs (aspirin, antibiotics, etc.) 5. Those who show the following results in the screening test - Serum AST and ALT levels greater than 1.5 times the upper limit of the normal range. - Creatinine clearance calculated using the CKD-EPI equation: 450 ms. - Individuals with positive results in serum tests for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), and syphilis. 6. Individuals with systolic blood pressure less than 90 mmHg or greater than 150 mmHg, or diastolic blood pressure less than 60 mmHg or greater than 100 mmHg, as measured in the supine position after a rest of 3 minutes during the screening examination. 7. Individuals with a history of drug abuse or those who test positive for abused substances in the urine screening test. 8. Individuals who have taken any prescription drugs or herbal medicines within two weeks before the expected first dosing day or any over-the-counter (OTC) drugs, health supplements, or vitamin supplements within one week before the anticipated first dosing day (unless other conditions are deemed appropriate by the investigator, allowing participation in the clinical trial), or those expected to take such medications. 9. Individuals who have taken drugs that induce or inhibit drug-metabolizing enzymes, such as barbiturates, within one month before the expected first dosing day. 10. Individuals who participated in other clinical trials or bioequivalence studies received investigational drugs within six months before the expected first dosing day. 11. Individuals who have donated whole blood within two months or component blood within one month before the expected first dosing day or received a blood transfusion within one month before the anticipated first dosing day. 12. Individuals who have a history of excessive caffeine consumption (more than five units per day) or cannot abstain from consuming caffeine-containing foods (such as coffee, tea (black tea, green tea, etc.), carbonated beverages, coffee-flavored milk, energy drinks, etc.) from 24 hours before each admission until the end of each discharge during the study period. 13. Individuals who have a history of excessive alcohol consumption (more than 21 units per week, where 1 unit equals 10 g of pure alcohol) or cannot abstain from alcohol during the period before the clinical trial. 14. Individuals who are current smokers (except those who quit smoking within the last three months and are eligible for selection as test subjects)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety & tolerability (self/other-awareness symptoms and adverse reactions);Safety & tolerability (physical examinations);Safety & tolerability (vital signs);Safety & tolerability (12-lead electrocardiogram);Safety & tolerability (clinical laboratory tests) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (blood) - AUClast, AUCinf, Cmax, Tmax, t1/2, CL/F, Vd/F, CLR, fe;Pharmacokinetics (urine) - AUClast, AUCinf, Cmax, Tmax, t1/2, CL/F, Vd/F, CLR, fe | — |
Countries
Korea, Republic of
Contacts
Public ContactSeoyoung Goh
Seoul National University Hospital
Outcome results
None listed