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

NCT02532712 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2016-01-27

No results posted yet for this study

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.

Conditions

  • Chemotherapy-Induced Neutropenia

Interventions

DRUG

EC-18

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

DRUG

Placebo

Placebo with same shape and size

Sponsors & Collaborators

  • Enzychem Lifesciences Corporation

    lead INDUSTRY

Principal Investigators

  • Min-Soo Park, Professor · Yonsei University Health System, Severance Hospital (Seoul)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02532712 on ClinicalTrials.gov