Clinical Trial

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

Recruiting Phase 1/2
View on ClinicalTrials.gov →
Record status
This record was last updated July 10, 2025 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-05-21; most recent amendment 2025-07-08.
Status change: Not Yet Recruiting → Recruiting 2025-06-08
Trial Details
NCT Number NCT06997627
Lead Sponsor GC Biopharma Corp
Conditions Tetanus-diphtheria-acellular Pertussis (Tdap)
Enrollment 120 participants
Start Date 2025-06-05
Primary Completion 2026-05 (estimated)
Study Completion 2026-05 (estimated)
Updated on ClinicalTrials.gov 2025-07-10