Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04480957 | Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects | PHASE1 | COMPLETED | 106 | — | — | Aug 4, 2020 | Jan 29, 2021 | Aug 18, 2021 | 1 | Singapore |
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...