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

GC Biopharma

Status and phase: Active, not recruiting; Phase 1

Conditions: COVID - 19

Treatments: Drug: Normal Saline; Biological: GC4006A

Study type: Interventional

Funder types: Industry

Identifiers

NCT07728396

GC4006A_COVID_P0101

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: All

Ages: 19 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

72 participants in 4 patient groups, including a placebo group

GC4006A (dose A)

Experimental group

Treatment:

Biological: GC4006A

GC4006A (dose B)

Experimental group

Treatment:

Biological: GC4006A

GC4006A (Dose C)

Experimental group

Treatment:

Biological: GC4006A

Normal Saline

Placebo Comparator group

Description:

Participants receive a single dose of placebo matching the volume of the active drug in their assigned cohort.

Treatment:

Drug: Normal Saline