Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mRNA-6231 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| mRNA-6231 Dose Level 1 | EXPERIMENTAL | In the single dose part of the study (Sentinel and Expansion Cohorts), each participant will receive 1 dose of Dose Level 1 of mRNA-6231 by subcutaneous injection on Day 1. In the repeat dose part of the study (Sentinel and Expansion Cohorts), each participant will receive up to 3 doses of Dose Level 1 of mRNA-6231 once every 2 weeks. |
| mRNA-6231 Dose Level 2 | EXPERIMENTAL | In the single dose part of the study (Sentinel and Expansion Cohorts), each participant will receive 1 dose of Dose Level 2 of mRNA-6231 by subcutaneous injection on Day 1. In the repeat dose part of the study (Sentinel and Expansion Cohorts), each participant will receive up to 3 doses of Dose Level 2 of mRNA-6231 once every 2 weeks. |
| mRNA-6231 Dose Level 3 | EXPERIMENTAL | In the single dose part of the study (Sentinel and Expansion Cohorts), each participant will receive 1 dose of Dose Level 3 of mRNA-6231 by subcutaneous injection on Day 1. In the repeat dose part of the study (Sentinel and Expansion Cohorts), each participant will receive up to 3 doses of Dose Level 3 of mRNA-6231 once every 2 weeks. |
| Name | Type | Description |
|---|---|---|
| mRNA-6231 | DRUG | Sterile frozen liquid dispersion for injection |
Key Inclusion Criteria: * Understand and agree to comply with the study procedures and provide written informed consent Key Exclusion Criteria: * Has received any investigational product (for example, study drug, biologic, device) within 30 days or 5 elimination half-lives, whichever is longer * ...
mRNA-6231 is an investigational drug being studied in healthy volunteers. It is being evaluated for safety, tolerability, pharmacokinetics, and pharmacodynamics in a Phase 1 clinical trial. The drug is not approved for any indication and is still in clinical development.
mRNA-6231 is being developed by Moderna, Inc., a biotechnology company traded on the Nasdaq under the ticker symbol MRNA. The company is conducting clinical research to evaluate the drug's safety and other properties in healthy adult participants.
mRNA-6231 is in Phase 1 clinical development. A Phase 1 study has been completed, which evaluated the drug in healthy adults. The drug is investigational and has not been approved by regulatory authorities.
mRNA-6231 has one completed clinical trial, identified as NCT04916431. This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of mRNA-6231 in healthy adults. The trial was conducted in Australia with 18 participants aged 18 years and older.
mRNA-6231 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial. The drug remains in clinical development and has not been authorized for use outside of clinical research settings.