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.
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 whether the Toxin Neutralization Antibody by TNA assay satisfy the NF50 standard or not at 4 weeks following infuse the optimal dose of GC1109 4 times in healthy adults. Secondary objective * Establish the safety of the GC1109 in healthy adults * Establish the GMT of Toxin Neutralization Antibody by TNA assay after infusing the drug 4 times until 24 weeks in healthy adults * Establish the GMT of Anti-PA IgG by ELISA after infusing the drug 4 times until 24 weeks in healthy adults
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
240
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.
Seoul National University Hospital
Seoul, South Korea
Step 1) Investigate the optimum volume of GC1109
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.
Time frame: at 4 weeks following infuse the drug 3 times
Step 2) Toxin Neutralization Antibody (by TNA assay) of GC1109
Percentage of subjects with an 0.56 or higher NF50 by evaluating Toxin Neutralization Antibody (by TNA assay) at 4 weeks following infuse the optimal dose of GC1109 4 times in healthy adults.
Time frame: at 4 weeks following infuse the drug 4 times
Step 1) Percentage of subjects after seroconversion
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
Time frame: for 4 weeks following infuse the drug 3 times
Step 1) Check the Seroprotection antibody titer
Check the Seroprotection antibody titer with passive immune (nonclinical tests) at 4 weeks following infuse the drug 3 times in healthy adults
Time frame: for 4 weeks following infuse the drug 3 times
Step 1) Seroconversion rate
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
Time frame: for 4 weeks following infuse the drug 3 times
Step 1) Compare the immunogenicity with GMT by TNA
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
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Time frame: for 4 weeks following infuse the drug 3 times
Step 1) Compare the immunogenicity with the GMT by ELISA
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
Time frame: for 4 weeks following infuse the drug 3 times
Step 1), Step 2) Adverse Events
Adverse events such as subjective and objective symptoms
Time frame: By 24 weeks following infuse the drug 4 times
Step 2) GMT of Toxin Neutralization Antibody by TNA assay
Establish the GMT of Toxin Neutralization Antibody by TNA assay after infusing the drug 4 times until 24 weeks in healthy adults
Time frame: By 24 weeks following infuse the drug 4 times
Step 2)GMT of Anti-PA IgG by ELISA
Establish the GMT of Anti-PA IgG by ELISA after infusing the drug 4 times until 24 weeks in healthy adults
Time frame: By 24 weeks following infuse the drug 4 times