Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARCT-021 Dose 1 · 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 Dose 1 is an investigational vaccine being studied for the prevention of SARS-CoV-2, the virus that causes COVID-19. It is currently in Phase 1 clinical development and is not yet approved for use.
ARCT-021 Dose 1 is being developed by Arcturus Therapeutics Holdings Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ARCT.
ARCT-021 Dose 1 is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
ARCT-021 Dose 1 was studied in a completed Phase 1 trial with the identifier NCT04480957. This was an ascending dose study in healthy adult subjects in Singapore, enrolling 106 participants.
ARCT-021 Dose 1 is a specific dose level of the investigational vaccine ARCT-021. The clinical trial NCT04480957 evaluated ascending doses of ARCT-021, with Dose 1 being one of the studied dose levels.