COVID - 19Phase 1NCT07728396
A Phase 1 Study to Evaluate the Safety and Immunogenicity of GC4006A in Healthy Adults
A Phase 1 study testing GC4006A and Normal Saline in people with COVID - 19, run by GC Biopharma Corp at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID - 19
- What is being tested?
- GC4006A and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Jan 2026to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 19-64 with written informed consent
- ≥16 weeks since last COVID-19 vaccination
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Conditions
- COVID - 19
- Being tested
- GC4006A, Normal Saline
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC4006ABiological
administered as a single dose via Intramuscular injection.
Normal SalineDrug
Matching placebo administered as a single dose via Intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| GC4006A (dose A) | Experimental | Not described Receives: Biological: GC4006A |
| GC4006A (dose B) | Experimental | Not described Receives: Biological: GC4006A |
| GC4006A (Dose C) | Experimental | Not described Receives: Biological: GC4006A |
| Normal Saline | Placebo comparator | Participants receive a single dose of placebo matching the volume of the active drug in their assigned cohort. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited local and systemic AEs
Measured: From baseline up to 7 days
Acute adverse events
Measured: From baseline up to 30 minutes
Unsolicited adverse AEs
Measured: From baseline up to 28 days
Secondary outcomes (3)
Serious adverse events (SAE), Adverse events of special interest (AESI), Medically Attended Adverse Events (MAAE)
Measured: From baseline up to week 52
Clinically significant findings in vital signs, laboratory tests, 12-lead electrocardiograms, and physical examinations
Measured: From baseline up to week 52
6. Immunogenicity response (SRR, GMT, GMFR for neutralizing antibodies; SRR, GMC, GMFR for binding antibodies)
SRR (Seroresponse rate), GMT (Geometric mean titer), GMFR (Geometric mean fold rise), GMC (Geometric mean concentration)
Measured: From baseline up to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start28 Jan 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID - 19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- GC Biopharma Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728396
- Sponsor's protocol ID
- GC4006A_COVID_P0101
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07728396
- Acronym / sponsor ID
- GC4006A_COVID_P0101
- Conditions
- COVID - 19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- GC Biopharma CorpIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GC4006A (dose A) | Experimental | Biological: GC4006A |
| GC4006A (dose B) | Experimental | Biological: GC4006A |
| GC4006A (Dose C) | Experimental | Biological: GC4006A |
| Normal Saline | Placebo comparator | Drug: Normal SalineParticipants receive a single dose of placebo matching the volume of the active drug in their assigned cohort. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 19-64 with written informed consent
- ≥16 weeks since last COVID-19 vaccination
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GC4006Aadministered as a single dose via Intramuscular injection. | Biological | GC4006A (Dose C), GC4006A (dose A), GC4006A (dose B) |
| Normal SalineMatching placebo administered as a single dose via Intramuscular injection. | Drug | Normal Saline |
Primary outcome
Solicited local and systemic AEs
Time frame: From baseline up to 7 days
Acute adverse events
Time frame: From baseline up to 30 minutes
Unsolicited adverse AEs
Time frame: From baseline up to 28 days
3 secondary outcomes
Serious adverse events (SAE), Adverse events of special interest (AESI), Medically Attended Adverse Events (MAAE)
Time frame: From baseline up to week 52
Clinically significant findings in vital signs, laboratory tests, 12-lead electrocardiograms, and physical examinations
Time frame: From baseline up to week 52
6. Immunogenicity response (SRR, GMT, GMFR for neutralizing antibodies; SRR, GMC, GMFR for binding antibodies)
Time frame: From baseline up to week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
Related trials for COVID - 19
RecruitingPhase 2
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only
Active, not recruitingObservational study
Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)
COVID-19 Vaccination
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GC4006A and Normal Saline in people with COVID - 19, run by GC Biopharma Corp at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Solicited local and systemic AEs (time frame: From baseline up to 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.