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RECRUITING
NCT06997627
PHASE1/PHASE2

A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults

Sponsor: GC Biopharma Corp

View on ClinicalTrials.gov

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

BIOLOGICAL

GC3111B

0.5 mL, Intramuscular injection

BIOLOGICAL

Boostrix®

0.5 mL, Intramuscular injection

Locations (1)

The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital

Seoul, South Korea