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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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In vitro and in vivo efficacy studies and clinical trials have shown that EC-18 has a mode of action of improving neutropenia by promoting neutrophil production from hematopoietic stem cells and at the same time, efficiently controlling STAT6/Complement 3(C3), suggesting its potential to be developed as an orally administered new drug for treatment of neutropenia resulting from decreased neutrophils caused by administration of an anticancer agent.

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.

Conditions

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Chemotherapy-Induced Neutropenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Single dose group-Group 1-Experimental

Single dose, 500mg of Study drug(EC-18)

Group Type EXPERIMENTAL

EC-18

Intervention Type DRUG

EC-18 Soft-capsule (500mg/1 capsule)

Single dose group-Group 1-Placebo

Single dose, 500mg of Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo with same shape and size

Single dose group-Group 2-Experimental

Single dose, 1000mg of Study drug(EC-18)

Group Type EXPERIMENTAL

EC-18

Intervention Type DRUG

EC-18 Soft-capsule (500mg/1 capsule)

Single dose group-Group 2-Placebo

Single dose, 1000mg of Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo with same shape and size

Single dose group-Group 3-Experimental

Single dose, 2000mg of Study drug (EC-18)

Group Type EXPERIMENTAL

EC-18

Intervention Type DRUG

EC-18 Soft-capsule (500mg/1 capsule)

Single dose group-Group 3-Placebo

Single dose, 2000mg of Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo with same shape and size

Single dose group-Group 4-Experimental

Single dose, 4000mg of Study drug (EC-18)

Group Type EXPERIMENTAL

EC-18

Intervention Type DRUG

EC-18 Soft-capsule (500mg/1 capsule)

Single dose group-Group 4-Placebo

Single dose, 4000mg of Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo with same shape and size

Multiple dose group-Group 1-Experimental

Multiple dose, Study drug(EC-18) 500mg, Once daily, for 14 days

Group Type EXPERIMENTAL

EC-18

Intervention Type DRUG

EC-18 Soft-capsule (500mg/1 capsule)

Multiple dose group-Group 1-Placebo

Multiple dose, Placebo 500mg, Once daily, for 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo with same shape and size

Multiple dose group-Group 2-Experimental

Multiple dose, Study drug(EC-18) 1000mg, Once daily, for 14 days

Group Type EXPERIMENTAL

EC-18

Intervention Type DRUG

EC-18 Soft-capsule (500mg/1 capsule)

Multiple dose group-Group 2-Placebo

Multiple dose, Placebo 1000mg, Once daily, for 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo with same shape and size

Multiple dose group-Group 3-Experimental

Multiple dose, Study drug(EC-18) 2000mg, Once daily, for 14 days

Group Type EXPERIMENTAL

EC-18

Intervention Type DRUG

EC-18 Soft-capsule (500mg/1 capsule)

Multiple dose group-Group 3-Placebo

Multiple dose, Placebo 2000mg, Once daily, for 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo with same shape and size

Multiple dose group-Group 4-Experimental

Multiple dose, Study drug(EC-18) 4000mg, Once daily, for 14 days

Group Type EXPERIMENTAL

EC-18

Intervention Type DRUG

EC-18 Soft-capsule (500mg/1 capsule)

Multiple dose group-Group 4-Placebo

Multiple dose, Placebo 4000mg, Once daily, for 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo with same shape and size

Interventions

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EC-18

EC-18 Soft-capsule (500mg/1 capsule)

Intervention Type DRUG

Placebo

Placebo with same shape and size

Intervention Type DRUG

Other Intervention Names

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EC18 Soft-capsule Placebo for EC-18 (Sofe-capsule)

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes