Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT01624532
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 Description:
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:
NCT01624532
Study Brief:
Protocol Section:
NCT01624532