NCT06997627 A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults
| NCT ID | NCT06997627 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | GC Biopharma Corp |
| Condition | Tetanus-diphtheria-acellular Pertussis (Tdap) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-06-05 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 120 participants in total. It began in 2025-06-05 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Healthy adults aged 19 to 64 years old as of the date of written consent. * Individuals with no history of vaccination with a vaccine containing diphtheria, tetanus, or pertussis antigens within the past 2 years prior to administration of the investigational product. Exclusion Criteria: * Individuals who have received a vaccine within 4 weeks prior to administration of the investigational product. * Individuals with a history of Tdap vaccination prior to administration of the investigational product. * Pregnant and breastfeeding women. * Individuals who have participated in other clinical trials involving investigational products/devices within 6 months prior to administration of the investigational product.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06997627 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 64 Years, studying Tetanus-diphtheria-acellular Pertussis (Tdap). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06997627 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06997627 currently recruiting?
Yes, NCT06997627 is actively recruiting participants. Contact the research team at minji.ko@gccorp.com for enrollment information.
Where is the NCT06997627 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06997627 clinical trial?
NCT06997627 is sponsored by GC Biopharma Corp. The trial plans to enroll 120 participants.