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

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: A Phase 2 Study to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109 Administered in Multi Intramuscular Doses to Healthy Subjects

Brief 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.

Detailed Summary:

  1. Step 1 Primary objective Investigate the optimum volume of GC1109 to compare the subject ratio after seroconversion in each Anti-PA Ab by TNA at 4 weeks following infuse the drug 3 times with the immunogenicity of each treatment (GC1109 and placebo cohort) in healthy adults.

    In healthy adults, three times the clinical dose of about four weeks, compare immunogenicity of each treatment group (GC1109 group and the placebo group) with subsects ratio who have been Seroconversion for Anti-PA Ab by TNA

    Secondary objective

    • Percentage of subjects after seroconversion in each anti-PA IgG level (by ELISA) at 4 weeks following infuse the drug 3 times in healthy adults
    • Check the Seroprotection antibody titer (survival rate : 50%) with passive immune (nonclinical tests) at 4 weeks following infuse the drug 3 times in healthy adults
    • Establish the Seroconversion rate from the percentage of subjects after seroconversion at 4 weeks following infuse the drug 3 times and seroprotection antibody titer in healthy adults
    • Compare the immunogenicity of each treatment with the GMT's assessment of Anti-PA Ab by TNA for 4 weeks following infuse the drug 3 times
    • Compare the immunogenicity of each treatment with the GMT's assessment of Anti-PA IgG by ELISA for 4 weeks following infuse the drug 3 times
    • Determine the safety of the each treatment cohort
  2. Step 2 Primary objective Evaluate the immunogenicity of GC1109 at 4 weeks following infuse the optimal dose drug 3 times, whethe
    Sponsor: Green Cross Corporation

    Current Primary Outcome: Investigate the optimum volume of GC1109 [ Time Frame: at 4 weeks following infuse the drug 3 times ]

    Investigate the optimum volume of GC1109 to compare the subject ratio after seroconversion in each Anti-PA Ab by TNA at 4 weeks following infuse the drug 3 times with the immunogenicity of each treatment (GC1109 and placebo cohort) in healthy adults.


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Percentage of subjects after seroconversion [ Time Frame: at 4 weeks following infuse the drug 3 times ]
      Percentage of subjects after seroconversion in each anti-PA IgG level (by ELISA) at 4 weeks following infuse the drug 3 times in healthy adults
    • Check the Seroprotection antibody titer [ Time Frame: at 4 weeks following infuse the drug 3 times ]
      Check the Seroprotection antibody titer with passive immune (nonclinical tests) at 4 weeks following infuse the drug 3 times in healthy adults
    • Seroconversion rate [ Time Frame: at 4 weeks following infuse the drug 3 times ]
      Establish the Seroconversion rate from the percentage of subjects after seroconversion at 4 weeks following infuse the drug 3 times and seroprotection antibody titer in healthy adults
    • Compare the immunogenicity with GMT by TNA [ Time Frame: for 4 weeks following infuse the drug 3 times ]
      Compare the immunogenicity of each treatment with the GMT's assessment of Anti-PA Ab by TNA for 4 weeks following infuse the drug 3 times
    • Compare the immunogenicity with the GMT by ELISA [ Time Frame: for 4 weeks following infuse the drug 3 times ]
      Compare the immunogenicity of each treatment with the GMT's assessment of Anti-PA IgG by ELISA for 4 weeks following infuse the drug 3 times
    • Adverse Events [ Time Frame: baseline through 8 months ]


    Original Secondary Outcome: Same as current

    Information By: Green Cross Corporation

    Dates:
    Date Received: March 6, 2012
    Date Started: November 2011
    Date Completion: November 2016
    Last Updated: February 24, 2016
    Last Verified: February 2016