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NCT Number: NCT07728396

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

COVID - 19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Korea University Guro Hospital

Seoul, 08308, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 19-64 with written informed consent
  • ≥16 weeks since last COVID-19 vaccination

Exclusion criteria

  • 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

Treatment and study plan

GC4006A

Biological

administered as a single dose via Intramuscular injection.

normal saline

Drug

Matching placebo administered as a single dose via Intramuscular injection.

Primary outcomes

  1. Solicited local and systemic AEs

    Time frame: From baseline up to 7 days

  2. Acute adverse events

    Time frame: From baseline up to 30 minutes

  3. Unsolicited adverse AEs

    Time frame: From baseline up to 28 days

Secondary outcomes

  1. Serious adverse events (SAE), Adverse events of special interest (AESI), Medically Attended Adverse Events (MAAE)

    Time frame: From baseline up to week 52

  2. Clinically significant findings in vital signs, laboratory tests, 12-lead electrocardiograms, and physical examinations

    Time frame: From baseline up to week 52

  3. 6. Immunogenicity response (SRR, GMT, GMFR for neutralizing antibodies; SRR, GMC, GMFR for binding antibodies)

    Time frame: From baseline up to week 52

    SRR (Seroresponse rate), GMT (Geometric mean titer), GMFR (Geometric mean fold rise), GMC (Geometric mean concentration)

Sponsors and collaborators

Lead sponsor

GC Biopharma Corp

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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