Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects
NCT04480957 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 106
Last updated 2021-08-18
Summary
Determine safety and tolerability and immungenicity of investigational vaccine ARCT-021 in healthy adult volunteers.
Conditions
Interventions
- BIOLOGICAL
-
ARCT-021 Dose 1
ARCT-021 Dose 1 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP)
- BIOLOGICAL
-
ARCT-021 Dose 2
ARCT-021 Dose 2 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
- BIOLOGICAL
-
ARCT-021 Dose 3
ARCT-021 Dose 3 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
- BIOLOGICAL
-
ARCT-021 Dose 4
ARCT-021 Dose 4 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
- BIOLOGICAL
-
ARCT-021 Dose Regimen 1
ARCT-021 dose regimen 1 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
- BIOLOGICAL
-
ARCT-021 Dose Regimen 2
ARCT-021 dose regimen 2 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
- OTHER
-
Placebo
Sterile 0.9% saline
Sponsors & Collaborators
-
Arcturus Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Jenny Low Guek Hong, MD · SingHealth Investigational Medicine Unit (IMU)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-08-04
- Primary Completion
- 2021-01-29
- Completion
- 2021-01-29
Countries
- Singapore
Study Locations
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