Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARCT-2138 · 1 trial · 1 indication
Solicited local AEs include injection-site pain, erythema and swelling
Solicited systemic AEs include fatigue, headache, myalgia, arthralgia, nausea, chills, and fever.
Spontaneously reported adverse events and as elicited by investigational site staff
Abnormal clinically significant values
Spontaneously reported adverse events and as elicited by investigational site staff
HAI antibody levels expressed as GMT, GMFI, SCRs and HAI titers.
ELLA antibody levels expressed as GMT, GMFI, SCRs and HAI titers.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 of ARCT-2138, younger adults | EXPERIMENTAL | Dose Level 1 of ARCT-2138 administered through intramuscular injection in the deltoid muscle. Interventions: Investigational Vaccine: ARCT-2138 |
| Cohort 2 of ARCT-2138, younger adults | EXPERIMENTAL | Dose Level 2 of ARCT-2138 administered through intramuscular injection in the deltoid muscle. Interventions: Investigational Vaccine: ARCT-2138 |
| Cohort 3 of ARCT-2138, younger adults | EXPERIMENTAL | Dose Level 3 of ARCT-2138 administered through intramuscular injection in the deltoid muscle. Interventions: Investigational Vaccine: ARCT-2138 |
| Cohort 4 of ARCT-2138, younger adults | EXPERIMENTAL | Dose Level 4 of ARCT-2138 administered through intramuscular injection in the deltoid muscle. Interventions: Investigational Vaccine: ARCT-2138 |
| Low Dose, younger and older adults | EXPERIMENTAL | Low dose level of ARCT-2138 administered through intramuscular injection in the deltoid muscle. Interventions: Investigational Vaccine: ARCT-2138 |
| Medium Dose, younger and older adults | EXPERIMENTAL | Medium dose level of ARCT-2138 administered through intramuscular injection in the deltoid muscle. Interventions: Investigational Vaccine: ARCT-2138 |
| High Dose, younger and older adults | EXPERIMENTAL | High dose level of ARCT-2138 administered through intramuscular injection in the deltoid muscle. Interventions: Investigational Vaccine: ARCT-2138 |
| Control Dose, younger adults | ACTIVE_COMPARATOR | Licensed Quadrivalent Vaccine administered through intramuscular injection in the deltoid muscle. Interventions: Control Vaccine: Licensed Quadrivalent Vaccine for younger adults |
| Control Dose, older adults | ACTIVE_COMPARATOR | Licensed Quadrivalent Vaccine administered through intramuscular injection in the deltoid muscle. Interventions: Control Vaccine: Licensed Quadrivalent Vaccine for older adults |
| Name | Type | Description |
|---|---|---|
| ARCT-2138 | BIOLOGICAL | Each participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle. |
| Licensed Quadrivalent Vaccine for younger adults | BIOLOGICAL | Each participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle. |
| Licensed Quadrivalent Vaccine for older adults | BIOLOGICAL | Each participant will receive one 0.5 mL intramuscular (IM) dose into the deltoid muscle. |
Inclusion Criteria: 1. Individuals are male, female, or transgender adults 18 to 49 years of age or 65 to 85 years of age. 2. Healthy participants or participants with pre-existing stable medical conditions. Pre-existing stable medical condition means a subject who: has full capacity of daily activ...
ARCT-2138 is an investigational vaccine being developed for the prevention of influenza in humans. It is currently in Phase 1 clinical development, meaning it is still being studied and has not been approved for use.
ARCT-2138 is being developed by Arcturus Therapeutics Holdings Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ARCT.
ARCT-2138 is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. A Phase 1 trial has been completed, but the vaccine remains in early-stage development.
ARCT-2138 was studied in a completed Phase 1 clinical trial registered as NCT06125691. This was a first-in-human, dose-ranging study of a self-amplifying RNA seasonal influenza vaccine in adults, conducted in Australia with 139 participants.
No, ARCT-2138 is not a monoclonal antibody. It is a self-amplifying RNA vaccine designed to prevent influenza. The modality listed for this asset is a vaccine, not an antibody therapy.
ARCT-2138 is a self-amplifying RNA vaccine. It works by delivering genetic instructions that prompt the body's cells to produce an immune response against influenza viruses, potentially providing protection against seasonal flu.