EC18-001: A Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics of EC-18 after oral administration in healthy male volunteers
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0001470
- Lead Sponsor
- Enzychem Lifesciences Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 64
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
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability assessments
- Secondary Outcome Measures
Name Time Method Pharmacokinetic assessment