Study to Evaluate the Safety, Tolerability and PK of EC-18 After Oral Administration in Healthy Volunteers
A Dose Block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Escalation, Phase I Clinical Trial to Evaluate the Safety, Tolerability and PK of EC-18 After Oral Administration in Healthy Male Volunteers
1 other identifier
interventional
64
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 4, 2015
CompletedFirst Posted
Study publicly available on registry
August 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 27, 2016
January 1, 2016
9 months
August 4, 2015
January 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
No. and severity of Adverse event as a Measure of Safety and Tolerability
From date of D-1 until Follow-up visit: up to 30 days
Vital signs, physical examination, clinical laboratory tests, ECG as a Measure of Safety and Tolerability
From date of screening until Follow-up visit: up to 60 days
Secondary Outcomes (17)
Pharmacokinetic parameters of EC-18 following single oral dose: Cmax (Maximum observed plasma drug concentration)
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: Tmax (Time of maximum drug concentration)
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: AUClast (Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration)
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: AUCinf (Area under the plasma concentration-time curve from time zero extrapolated to the infinite time)
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
Pharmacokinetic parameters of EC-18 following single oral dose: t1/2 (Half-life)
[0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post dose
- +12 more secondary outcomes
Study Arms (16)
Single dose group-Group 1-Experimental
EXPERIMENTALSingle dose, 500mg of Study drug(EC-18)
Single dose group-Group 1-Placebo
PLACEBO COMPARATORSingle dose, 500mg of Placebo
Single dose group-Group 2-Experimental
EXPERIMENTALSingle dose, 1000mg of Study drug(EC-18)
Single dose group-Group 2-Placebo
PLACEBO COMPARATORSingle dose, 1000mg of Placebo
Single dose group-Group 3-Experimental
EXPERIMENTALSingle dose, 2000mg of Study drug (EC-18)
Single dose group-Group 3-Placebo
PLACEBO COMPARATORSingle dose, 2000mg of Placebo
Single dose group-Group 4-Experimental
EXPERIMENTALSingle dose, 4000mg of Study drug (EC-18)
Single dose group-Group 4-Placebo
PLACEBO COMPARATORSingle dose, 4000mg of Placebo
Multiple dose group-Group 1-Experimental
EXPERIMENTALMultiple dose, Study drug(EC-18) 500mg, Once daily, for 14 days
Multiple dose group-Group 1-Placebo
PLACEBO COMPARATORMultiple dose, Placebo 500mg, Once daily, for 14 days
Multiple dose group-Group 2-Experimental
EXPERIMENTALMultiple dose, Study drug(EC-18) 1000mg, Once daily, for 14 days
Multiple dose group-Group 2-Placebo
PLACEBO COMPARATORMultiple dose, Placebo 1000mg, Once daily, for 14 days
Multiple dose group-Group 3-Experimental
EXPERIMENTALMultiple dose, Study drug(EC-18) 2000mg, Once daily, for 14 days
Multiple dose group-Group 3-Placebo
PLACEBO COMPARATORMultiple dose, Placebo 2000mg, Once daily, for 14 days
Multiple dose group-Group 4-Experimental
EXPERIMENTALMultiple dose, Study drug(EC-18) 4000mg, Once daily, for 14 days
Multiple dose group-Group 4-Placebo
PLACEBO COMPARATORMultiple dose, Placebo 4000mg, Once daily, for 14 days
Interventions
EC-18 Soft-capsule (500mg/1 capsule)
Placebo with same shape and size
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yonsei University Health System, Severance Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Min-Soo Park, Professor
Yonsei University Health System, Severance Hospital (Seoul)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2015
First Posted
August 26, 2015
Study Start
March 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
January 27, 2016
Record last verified: 2016-01