None listed
Conditions
Interventions
Drug : Investigational product name: AVI-CO-004/ Multiple ascending dose of 200mg, 400mg , oral injection each 4 times
The placebo is totally indentical with investicational product except active in
Sponsors
Avixgen
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Adult male of age 20~45, at the screening. 2) Individual having weight within ideal body weight ±20% and over 55kg. Ideal body weight = (Height cm - 100) X 0.9 3) Individual certainly consented to not donate sperms to 3 months after finishing of test and to use contraception during clinical test. 4) Individual consented by letter to determine involvement by themselves and to follow requirement after listening minutely about this clinical study
Exclusion criteria
Exclusion criteria: 1) Individual with clinically significant and active cardiovascular diseases, respiratory diseases, renal diseases, endocrine disorders, hematologic diseases, digestive disorders, central nervous system disorders, mental illness or malignant tumor or Individual having any history of aforementioned diseases. 2) Individual having gastrointestinal diseases that can affect the absorption of drugs (Crohn’s disease, ulcers, acute or chronic pancreatitis, etc.) or having a history of gastrointestinal surgery (however, simple appendectomy or hernia surgery are excluded). 3) Individual who has hypersensitivity or has history of clinically significant hypersensitivity reactions to the active ingredient. 4) Individual who considered unsuitable through health examination that are performed during screening (Disease history, physical examination, vital signs, ECG, laboratory tests, etc.) 5) Individual who has laboratory test results showing the numbers of those below - Hemoglobin < 13.0 g/dL - Serum AST or ALT > 1.25 times the normal limit. - Serum total bilirubin > 1.25 times the normal limit. - Serum Creatin phosphokinase(CPK) > 1.25 times the normal limit. -In case of eGFR (estimated Glomerular Filtration Rate) <60 mL / min / 1.73m2 using the MDRD (Modification of Diet in Renal Disease) formula 6) After achieving stability more than 5 minutes in a sitting posture, Individual showing vital sign readings for the systolic blood pressure = 150 mmHg or =100mmHg, for diastolic blood pressure = 100 mmHg or = 65 mmHg. 7) 12-lead ECG examination result showing that QTcB interval is more than 450ms. 8) Individual having history of drug abuse or showing positive results for drugs abuse in drug screening tests. 9) Individual who has taken excessive of caffeine, alcohol or cigarette ( Caffeine :> 5 cups / day, Alcohol :> 210g / week, Cigarette: > 10 cigarettes / day). 10) Individual who has taken test drugs from other clinical tests within 90 days prior to test drug administration. 11) Individual who has taken the drugs that induce and suppress drug-metabolizing enzymes, such as barbiturates, within 30 days prior to test drug administration. 12) Individual who has done whole blood donation within 60 days or Individual who has done apheresis blood donation within 30 days prior to the test drug administration. 13) Individual who has Taken food containing grapefruit (example: >1L grapefruit drink) within 7 days prior to the test drug administration 14) Individual who has taken medicine, Korean traditional medicine, or vitamin pills within 14 days before test drug administration. 15) Individual who considered unsuitable by investigators due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUClast;Tmax, T1/2;Cmax, maximum drug concentration in plasma | — |
Countries
Korea, Republic of
Contacts
Public ContactSang il Jeon
The Catholic University of Korea
Outcome results
None listed