A Phase 1 Study to Evaluate the Safety and Immunogenicity of GC4006A in Healthy Adults

Phase 1Active Not RecruitingNCT07728396

GC Biopharma Corp72 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

COVID - 19

Interventions

GC4006ABIOLOGICAL

administered as a single dose via Intramuscular injection.

Normal SalineDRUG

Matching placebo administered as a single dose via Intramuscular injection.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Korea University Guro Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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

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)

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

Time frame: From baseline up to week 52

Data from ClinicalTrials.gov

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