None listed
Conditions
Interventions
Drug : Drug name: AVI-CO-004/ Single ascending dose/ oral injection
The placebo is totally identical without active ingredient.
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 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) 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 done whole blood donation within 60 days or Individual who has done apheresis blood donation within 30 days prior to the test drug administration. 14) Individual who has taken preion drug, 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;Clearance, CLR ;Tmax, T1/2 ; Cmax, maximum drug concentration in plasma, | — |
Countries
Korea, Republic of
Contacts
Public ContactSunil Youn
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed