None listed
Conditions
Interventions
Drug : Drug Name: ES16001
Target: Healthy Adult Volunteers
Step 1: 32 (8 per cohort)
Step 2: 16 (8 per cohort)
6 test subjects per cohort, 2 placebo subjects per cohort (total of 8)
Dosage and admini
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adults aged 20 or older and 45 or younger at the time of screening test - A person who has no congenital or treatment-related chronic disease and has no pathological symptoms or findings as a result of an internal examination; - A person who is deemed suitable for clinical trials as a result of laboratory and ECG tests such as serum tests, hematologic tests, hemochemical tests, and urinary tests during screening tests 2. A person who weighs more than 55 kg at the time of screening and weighs less than ±20% of the ideal body weight. * Ideal body weight = (height (cm) - 100) × 0.9) 3. A person who agrees not to donate sperm during the clinical trial period and up to three months after the end of the trial. 4. Persons identified as non-pregnant 5. A person who, after receiving a detailed explanation of this clinical trial, voluntarily decided to participate and agreed in writing to comply with the precautions
Exclusion criteria
Exclusion criteria: 1. A person with a medical history such as clinically significant and/or active cardiovascular, respiratory system, kidney, endocrine system, hematology, digestive system, central nervous system, mental illness, or malignancy 2. Persons with a history of gastrointestinal diseases (cron disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of drugs for clinical trials 3. A person with a history of hypersensitivity reaction to any medications or additives for clinical trials 4. A person who is deemed inappropriate for the clinical trial through a medical examination (disease intensity, physical examination, vital signs, ECG examination, laboratory examination, etc.) conducted during screening. 5. A person who shows the following laboratory test results - Hemoglobin 1.5 times the upper limit - 1.5 times the upper limit of CPK in blood - MDRD (Modification of Diet in Renal Disease) 150 mmHg or 100 mmHg or 5 cups/day, alcohol: >210 g/week, tobacco: >10 pcs/day) 11. A person who has received a clinical trial drug within 180 days prior to the administration of a clinical trial drug 12. A person who has taken medication that induces and inhibits metabolic enzymes such as barbital drug within 30 days prior to administration of a clinical trial drug 13. A person who has donated whole blood within 60 days prior to administration of a clinical trial drug, or a person who has donated blood within 30 days prior to administration of a clinical trial drug, or who has received blood transfusion within 30 days 14. A person who has consumed grapefruit-containing food (e.g. > 1L or more grapefruit-containing beverages) within 14 days prior to administration of the clinical trial drug 15. A person who has taken a specialized medicine, herbal medicine, general medicine, or vitamin pill within 14 days prior to administration of a clinical trial drug 16. A person who determines that the tester is unfit to participate in a clinical trial due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital sign;Laboratory test results | — |
Countries
Korea, Republic of
Contacts
Public ContactByungwook
Seoul National University Hospital
Outcome results
None listed