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Clinical Trials/NCT01867957
NCT01867957CompletedPhase 1

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

Seoul National University Hospital1 site in 1 country20 target enrollmentStarted: February 1, 2009Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Adverse Event
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

  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.
  1. STUDY DESIGN
  • single-blinded
  • randomized
  • placebo controlled
  • phase 1 study

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

High-dose GC1109

Experimental

Intervention: High-dose GC1109 (Biological)

Low-dose Placebo

Placebo Comparator

Intervention: Low-dose Placebo (Biological)

High-dose Placebo

Placebo Comparator

Intervention: High-dose Placebo (Biological)

Low-dose GC1109

Experimental

Intervention: Low-dose GC1109 (Biological)

Outcomes

Primary Outcomes

Adverse Event

Time Frame: 0 - 28 Days

Secondary Outcomes

  • Anti-protective antigen(PA) antibody level (by TNA)(Day 14, Day 28)
  • Anti-PA Immunoglobulin G (IgG) (by ELISA)(Day 14, Day 28)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Myoung-don Oh

Professor, Division of Infectious Diseases, Department of Internal Medicine

Seoul National University Hospital

Study Sites (1)

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