A Phase 2 Study to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109 Administered in Multi Intramuscular Doses to Healthy Subjects
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Anthrax
- Sponsor
- Green Cross Corporation
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Step 2) Toxin Neutralization Antibody (by TNA assay) of GC1109
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy 18 to 55 year-olds of either sex
- •Body mass index above 18.5kg/m2 or below 30kg/m2 at the screening time
- •A medical history without clinically significant congenital or chronic disease at the screening test before administrating the study drug within 28 days
- •Agreement to avoid pregnancy or use contraceptive measure between 1 week prior to first dose and the 4 weeks following the final administration
- •Female subjects of childbearing age, have negative serum β-HCG prior to infuse the study drug within 7 days and urine test at the every pre-vaccine
- •Signed, informed voluntarily consents the clinical trials
- •Willingness and agreement to comply with the constraints of the study protocol and ability to understand the study
- •Willingness and ability to return for all follow-up visits and blood draws for the duration of the study
- •Subjects who can have the study vaccine administered into the deltoid muscle and don't have the tattoo
- •Agreement to stop drinking for 7days following the administration of the each study vaccine
Exclusion Criteria
- •Prior history of, or known exposure to any form of B.anthracis or any anthrax immunization
- •Employment in an industry involved in contact with ruminant animals, slaughterhose workers, handle the animal raw hides or raw wool, veterinary sciences involving ruminant animals, suspect exposure to any form of B. or anthrax immunization producer and developer.
- •HIV positive or syphilis HAV, HBV, HCV positive or suspect
- •Clinically significant out-of-range of laboratory tests at screening including : hypernatremia, hyponatremia, hypopotassemia, hyperchloremia, hypoproteinemia
- •Prior history of, immunodeficiency or clinically active autoimmune disease
- •Subjects with a history of Guillain-Barre syndrome
- •Subjects with hemophilia or being treated with an anticoagulant who are at increased risk of serious bleeding during intramuscular injection
- •History or evidence of metastatic malignancy tumor for internal organs, blood or flesh
- •Medical significant hypersensitivity or idiosyncratic reaction related to any medical product including study drug or with a history of anaphylaxis
- •Subjects who have had an acute fever exceeding a body temperature of 38.0℃ within 72 hours prior to the administration of the study vaccine, or who have had a symptom suspicious for acute febrile disease within 14 days prior to the administration of the study vaccine.
Outcomes
Primary Outcomes
Step 2) Toxin Neutralization Antibody (by TNA assay) of GC1109
Time Frame: at 4 weeks following infuse the drug 4 times
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.
Step 1) 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.
Secondary Outcomes
- Step 1) Percentage of subjects after seroconversion(for 4 weeks following infuse the drug 3 times)
- Step 1) Compare the immunogenicity with the GMT by ELISA(for 4 weeks following infuse the drug 3 times)
- Step 1), Step 2) Adverse Events(By 24 weeks following infuse the drug 4 times)
- Step 2) GMT of Toxin Neutralization Antibody by TNA assay(By 24 weeks following infuse the drug 4 times)
- Step 1) Check the Seroprotection antibody titer(for 4 weeks following infuse the drug 3 times)
- Step 1) Seroconversion rate(for 4 weeks following infuse the drug 3 times)
- Step 1) Compare the immunogenicity with GMT by TNA(for 4 weeks following infuse the drug 3 times)
- Step 2)GMT of Anti-PA IgG by ELISA(By 24 weeks following infuse the drug 4 times)