A Phase 1 Study to Evaluate the Safety and Immunogenicity of GC4006A in Healthy Adults
A Phase 1, Randomized, Double-blind, Dose-Escalation, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of the COVID-19 Preventive Vaccine 'GC4006A' in Healthy Adults Aged 19 to 64 Years
1 other identifier
interventional
72
1 country
1
Brief Summary
A Phase 1, Randomized, Double-blind, Dose-Escalation, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of the COVID-19 Preventive Vaccine 'GC4006A' in Healthy Adults Aged 19 to 64 Years
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 28, 2026
CompletedFirst Submitted
Initial submission to the registry
July 15, 2026
CompletedFirst Posted
Study publicly available on registry
July 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
July 27, 2026
July 1, 2026
1.3 years
July 15, 2026
July 21, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Solicited local and systemic AEs
From baseline up to 7 days
Acute adverse events
From baseline up to 30 minutes
Unsolicited adverse AEs
From baseline up to 28 days
Secondary Outcomes (3)
Serious adverse events (SAE), Adverse events of special interest (AESI), Medically Attended Adverse Events (MAAE)
From baseline up to week 52
Clinically significant findings in vital signs, laboratory tests, 12-lead electrocardiograms, and physical examinations
From baseline up to week 52
6. Immunogenicity response (SRR, GMT, GMFR for neutralizing antibodies; SRR, GMC, GMFR for binding antibodies)
From baseline up to week 52
Study Arms (4)
GC4006A (dose A)
EXPERIMENTALGC4006A (dose B)
EXPERIMENTALGC4006A (Dose C)
EXPERIMENTALNormal Saline
PLACEBO COMPARATORParticipants receive a single dose of placebo matching the volume of the active drug in their assigned cohort.
Interventions
administered as a single dose via Intramuscular injection.
Matching placebo administered as a single dose via Intramuscular injection.
Eligibility Criteria
You may qualify if:
- Age 19-64 with written informed consent
- ≥16 weeks since last COVID-19 vaccination
You may not qualify if:
- Positive SARS-CoV-2 test (RT-PCR/Rapid Antigen) at screening or randomization
- \<16 weeks since COVID-19 diagnosis
- History of serious adverse event, allergy, or hypersensitivity to the vaccines
- Pregnant or lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea University Guro Hospital
Seoul, 08308, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2026
First Posted
July 27, 2026
Study Start
January 28, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
July 27, 2026
Record last verified: 2026-07