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Also known as ARCT-021 Dose 1
ARCT-021 · 1 trial · 1 indication
Safety and tolerability of ARCT-021 assessed by determining the incidence, severity and dose-relationship of AEs by dose
| Arm | Type | Description |
|---|---|---|
| Escalation Cohort dose 1 of ARCT-021, 21 - 55 years | EXPERIMENTAL | Escalation Cohort dose 1 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle. |
| Escalation Cohort dose 2 of ARCT-021, 21 -55 years | EXPERIMENTAL | Escalation Cohort dose 2 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle. |
| Escalation Cohort dose 3 of ARCT-021, 21 - 55 years | EXPERIMENTAL | Escalation Cohort dose 3 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle. |
| Escalation Cohort dose 4 of ARCT-021, 21 - 55 years | EXPERIMENTAL | Escalation Cohort dose 4 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle. |
| Expansion cohort dose regimen 1, 21 - 55 years. | EXPERIMENTAL | Expansion cohort dose regimen 1, administered through 0.5 mL intramuscular injection in the deltoid muscle. |
| Expansion cohort dose regimen 2, 21 - 55 years. | EXPERIMENTAL | Expansion cohort dose regimen 2, administered through 0.5 mL intramuscular injection in the deltoid muscle. |
| Expansion cohort dose regimen 1, 56 - 80 years | EXPERIMENTAL | Expansion cohort dose regimen 1, administered through 0.5 mL intramuscular injection in the deltoid muscle. |
| Expansion cohort dose regimen 2, 56 - 80 years | EXPERIMENTAL | Expansion cohort dose regimen 2, administered through 0.5 mL intramuscular injection in the deltoid muscle. |
| Name | Type | Description |
|---|---|---|
| ARCT-021 Dose 1 | BIOLOGICAL | 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) |
| ARCT-021 Dose 2 | BIOLOGICAL | 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 |
| ARCT-021 Dose 3 | BIOLOGICAL | 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 |
| ARCT-021 Dose 4 | BIOLOGICAL | 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 |
| ARCT-021 Dose Regimen 1 | BIOLOGICAL | 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 |
| ARCT-021 Dose Regimen 2 | BIOLOGICAL | 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 |
| Placebo | OTHER | Sterile 0.9% saline |
Inclusion Criteria: 1. Healthy males or females aged 21 to 80 at the time of informed consent. 2. Body Mass Index 18-35 kg/m2, inclusive, at screening 3. Willing to refrain from strenuous exercise/activity (for example heavy lifting, weight training, intense aerobics classes etc.) and alcohol for a...
ARCT-021 is an investigational product developed for SARS-CoV-2, the virus that causes COVID-19. It was studied in a Phase 1 clinical trial in healthy adult volunteers. It is not an approved product and remains in clinical development.
ARCT-021 is being developed by Arcturus Therapeutics Holdings Inc., which trades under the ticker ARCT. The company sponsored the Phase 1 study of the candidate in Singapore.
ARCT-021 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. The candidate is investigational and has not been approved for any indication.
ARCT-021 was evaluated in a single Phase 1 trial, NCT04480957, titled an ascending dose study of investigational SARS-CoV-2 vaccine ARCT-021 in healthy adult subjects. The trial enrolled 106 participants in Singapore, was randomized, double-blind, and controlled, and has been completed.
Yes, ARCT-021 Dose 1 is another name used for ARCT-021. Both refer to the same investigational candidate developed by Arcturus Therapeutics for SARS-CoV-2.