None listed
Conditions
Interventions
Drug : This trial is will be conducted as randomized and double-blind by dose group, with a total of 4 dose groups - Group 1 (low-dose group, 500 mg), Group 2 (medium-dose group, 1000 mg), Group 3 (hi
Sponsors
Enzychem Lifesciences Corporation
Novotech Asia Korea
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy adult male aged between 19 and 45 years, inclusive, at the time of providing the informed consent form 2) Body weight = 50 kg, and calculated BMI in the range of 18.5 kg/m2 = BMI < 25.0 kg/m2 ? BMI(body mass index) = Body weight (kg)/[height (m)]2 3) No inherited or chronic disease and pathologic symptoms or findings from internal examinations 4) Eligible subject based on findings from clinical laboratory tests, such as hematology, blood chemistry, urinalysis and immunoserology, and ECG, as conducted by a responsible doctor depending on characteristics of the drug 5) Written consent on voluntary decision of participation and compliance with precautions after being fully informed of and completely understanding this trial 6) Consent to practice medically acceptable contraception during the trial
Exclusion criteria
Exclusion criteria: 1) Hypersensitivity to a drug containing an ingredient of the investigational product (EC-18) or similar ingredient (e.g., deer antler) or other drugs (e.g., aspirin, antibiotics) or medical history of clinically significant hypersensitivity 2) Active infection such as chronic or local infection based on screening tests or inquiry, verifiable medical records 3) Serious infection that required hospitalization or use of antibiotics within 30 days prior to the first dose of the investigational product, based on an inquiry or verifiable medical records 4) Presence of a clinically significant hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous, blood, cardiovascular, urogenital, psychiatric disorder or its prior history 5) (1) Presenting tuberculosis or prior history of tuberculosis or (2) positive results from a QuantiFERON®-TB Gold in Tube Assay conducted due to a contact with a tuberculosis patient within the past 3 months or signs and symptoms of suspected tuberculosis 6) Prior history of a gastrointestinal disorder (e.g., Crohn's disease, ulcer) or surgery (except for simple appendectomy or hernia surgery) that may affect drug absorption, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability assessments | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactMin- Park
Yonsei University Health System, Severance Hospital
Outcome results
None listed