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A Study to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109

NCT01624532 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2023-01-04

No results posted yet for this study

Summary

The purpose of this study is to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109 Administered in Multi Intramuscular Doses to Healthy Subjects.

Conditions

  • Anthrax

Interventions

BIOLOGICAL

GC1109 or Placebo of GC1109

Step1: Administer 0.3mL or 0.5mL or 0.1mL or placebo of GC1109 into the deltoid muscle three times every four weeks. Step2: Administer 1.0mL of GC1109 or placebo of GC1109 into the deltoid muscle three times every four weeks, and once after 24 weeks.

Sponsors & Collaborators

  • Korean Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Green Cross Corporation

    lead INDUSTRY

Principal Investigators

  • Nam Joong Kim, M.D. · Seoul National University Hospital

  • Seong Heon Wie, M.D. · Saint Vincent's Hospital, Korea

  • Won Suk Choi, M.D. · Korea University Asan Hospital

  • Eun Jung Lee, M.D. · Soonchunhyang University Hospital

  • Jacob Lee, M.D. · Hallym University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-14
Primary Completion
2022-08-02
Completion
2022-12-19

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 NCT01624532 on ClinicalTrials.gov