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A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults
Sponsor: GC Biopharma Corp
Summary
This clinical trial consists of two parts: Part 1, which explores safety, and Part 2, which examines both safety and efficacy (immunogenicity). Part 1 is a single-center, open-label, single-group study, while Part 2 is designed as a multicenter, double-blind, randomized, active-controlled trial.
Official title: An Open(Part 1), Single-arm(Part 1), Randomized(Part 2), Double-blind(Part 2), Active-controlled(Part 2) Phase I/II Clinical Trial to Evaluate the Safety and Efficacy (Immunogenicity) of GC3111B in Healthy Adults
Key Details
Gender
All
Age Range
19 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-06-05
Completion Date
2026-05
Last Updated
2025-07-10
Healthy Volunteers
Yes
Interventions
GC3111B
0.5 mL, Intramuscular injection
Boostrix®
0.5 mL, Intramuscular injection
Locations (1)
The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital
Seoul, South Korea