Efficacy and Safety of Anthrax Vaccine, GC1109

A Single Blind, Randomized, Placebo Control, Phase I Study to Evaluate the Safety and Immunogenicity of the GC1109 Administered by the Intramuscular Route in Healthy Men

1. BACKGROUND The newly developed anthrax vaccine GC1109 has been proven safe and effective in preclinical studies.

2. OBJECTIVE

   - To evaluate the immunogenicity and safety of the anthrax vaccine GC1109 in healthy male volunteers.

3. STUDY DESIGN

   • single-blinded
   • randomized
   • placebo controlled
   • phase 1 study

Inclusion Criteria:

1. Healthy male subjects between 18 and 45 years of age at the time of screening visit
2. 18.5kg/m2 ≤BMI < 30kg/m2 at the time of screening visit
3. Subjects without congenital or chronic disorder

Exclusion Criteria:

-