Overview

Study to Evaluate the Safety, Tolerability and PK of EC-18 After Oral Administration in Healthy Volunteers

Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
Male
Summary
This study is a Dose block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Escalation, Phase I clinical trial to assess the safety, tolerability and pharmacokinetics of single-dose and multiple-dose oral administration of the investigational product, EC-18 (study drug) in healthy adult male volunteers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Enzychem Lifesciences Corporation
Criteria
Inclusion Criteria:

- Healthy adult male aged between 19 and 45 years, inclusive, at the time of providing
the informed consent form

- 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

- No inherited or chronic disease and pathologic symptoms or findings from internal
examinations

- 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

- Written consent on voluntary decision of participation and compliance with precautions
after being fully informed of and completely understanding this trial

- Consent to practice medically acceptable contraception during the trial

Exclusion Criteria:

- 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

- Active infection such as chronic or local infection based on screening tests or
inquiry, verifiable medical records

- 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

- Presence of a clinically significant hepatic, renal, gastrointestinal, respiratory,
musculoskeletal, endocrine, nervous, blood, cardiovascular, urogenital, psychiatric
disorder or its prior history

- (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

- 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.