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mRNA-0184 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SAD Stage: mRNA-0184 | EXPERIMENTAL | Participants will receive a single dose of mRNA-0184. |
| MAD Stage: mRNA-0184 | EXPERIMENTAL | Participants will receive up to 4 doses of mRNA-0184 administered over a treatment period of up to 16 weeks. |
| MAD Stage: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching to mRNA-0184 administered over a treatment period of up to 16 weeks. |
| Name | Type | Description |
|---|---|---|
| mRNA-0184 | DRUG | mRNA-0184 dispersion for intravenous (IV) infusion |
| Placebo | DRUG | 0.9% sodium chloride (normal saline) injection |
Key Inclusion Criteria: * Documented diagnosis of heart failure (HF) based on medical records. * Left ventricular ejection fraction (LVEF) ≥ 35% and \< 50% at Screening, or documented within the 3 months before Screening, measured by transthoracic echocardiogram (TTE) or cardiac magnetic resonance ...
mRNA-0184 is an investigational RNA therapy being developed for chronic heart failure. It is designed as a treatment for patients with this cardiovascular condition, a population that includes adults 18 years and older. It has not been approved for any use and remains in clinical development.
mRNA-0184 targets relaxin, a hormone. By directing cells to produce relaxin, the therapy aims to act on the hormone pathway relevant to chronic heart failure. Relaxin is a naturally occurring hormone that influences cardiovascular function, and the mRNA approach is intended to deliver it therapeutically.
mRNA-0184 is being developed by Moderna, Inc., which trades on the Nasdaq under the ticker MRNA. Moderna is the sponsor of the clinical program evaluating the therapy in chronic heart failure. The company's pipeline includes this RNA therapy as part of its cardiovascular research efforts.
mRNA-0184 is in Phase 1 clinical development. The single Phase 1 trial evaluating it has been completed, and the drug is not approved by the FDA. It remains an investigational therapy for chronic heart failure, with no later-stage trials reported.
mRNA-0184 has been studied in one Phase 1 trial, NCT05659264, titled A Study to Evaluate the Safety of mRNA-0184 in Participants With Heart Failure. The trial enrolled 48 adults with chronic heart failure across the United States, Poland, and the United Kingdom, and it is now completed.
The Phase 1 trial NCT05659264 was a randomized, placebo-controlled study that enrolled 48 participants with chronic heart failure. It was not double-blind and did not select patients by biomarker. Participants were adults 18 years and older, and the study was conducted in the United States, Poland, and the United Kingdom.