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Safety and Efficacy of GX-188E Administered Via EP Plus GX-I7 or Imiquimod.

NCT03206138 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-07-02

No results posted yet for this study

Summary

This is a study to investigate the safety and efficacy of GX-188E administered IM plus local administration of GX-I7 or Imiquimod at cervix in subjects with cervical intraepithelial neoplasia (CIN) 3.

Conditions

  • Cervical Intraepithelial Neoplasia 3

Interventions

BIOLOGICAL

GX-188E, GX-I7

Experimental: 1mg of GX-188E administered IM using EP device 3 times and 3mg of GX-I7 administered in cervix 4 times.

BIOLOGICAL

GX-188E, Imiquimod

1mg of GX-188E administered IM using EP device 3 times and 12.5mg of Imiquimod application at cervix 8 times.

Sponsors & Collaborators

  • Genexine, Inc.

    collaborator INDUSTRY

  • Seoul St. Mary's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-30
Primary Completion
2018-10-31
Completion
2018-10-31

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 NCT03206138 on ClinicalTrials.gov