NCT06997627

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: GC Biopharma Corp · Industry
• Sex: All
• Age: 19 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tetanus-diphtheria-acellular Pertussis (Tdap)

Interventions

Type	Name	Description
BIOLOGICAL	GC3111B	0.5 mL, Intramuscular injection
BIOLOGICAL	Boostrix®	0.5 mL, Intramuscular injection

Timeline

• Start date: 2025-06-05
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-05-30
• Last updated: 2025-07-10

Locations

1 site across 1 country: South Korea