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Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GX-E2 in Healthy Subjects

NCT02291991 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-01-29

No results posted yet for this study

Summary

This is a randomized, placebo controlled, single dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GX-E2 in healthy male subjects.

Conditions

  • Healthy

Interventions

DRUG

GX-E2

Investigational drug(GX-E2 or Placebo) will be administered to healthy volunteers by the intravenous route.

DRUG

GX-E2

Investigational drug(GX-E2 or Placebo) will be administered to healthy volunteers by the intravenous route.

Sponsors & Collaborators

  • Genexine, Inc.

    lead INDUSTRY

Principal Investigators

  • KyungSang Yu, M.D. · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • South Korea

Study Locations

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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 NCT02291991 on ClinicalTrials.gov