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mRNA-0184 · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Single Ascending Dose (SAD): mRNA-0184 | EXPERIMENTAL | Participants will receive a single subcutaneous (SC) injection of a fixed dose of mRNA-0184 on Day 1. |
| Multiple Ascending Dose (MAD): mRNA-0184 | EXPERIMENTAL | Participants will receive up to 2 SC injections of a fixed dose of mRNA-0184 on Days 1 and 15. |
| Cohort 1: mRNA-0184 Dose Level A | EXPERIMENTAL | Sequence 1: Participants will receive infusion condition 1 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 2 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 2 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 1 of mRNA-0184 on Day 22. |
| Cohort 2: mRNA-0184 Dose Level B | EXPERIMENTAL | Sequence 1: Participants will receive infusion condition 1 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 2 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 2 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 1 of mRNA-0184 on Day 22. |
| Cohort 3: mRNA-0184 Dose Level C | EXPERIMENTAL | Sequence 1: Participants will receive infusion condition 1 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 2 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 2 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 1 of mRNA-0184 on Day 22. |
| Cohort 4: mRNA-0184 Dose Level D | EXPERIMENTAL | Sequence 1: Participants will receive infusion condition 3 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 4 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 4 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 3 of mRNA-0184 on Day 22. |
| Cohort 5: mRNA-0184 Dose Level E | EXPERIMENTAL | Sequence 1: Participants will receive infusion condition 5 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 6 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 6 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 5 of mRNA-0184 on Day 22. |
| Cohort 6: mRNA-0184 Dose Level F | EXPERIMENTAL | Sequence 1: Participants will receive infusion condition 5 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 6 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 6 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 5 of mRNA-0184 on Day 22. |
| 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 | SC injection |
| Placebo | DRUG | 0.9% sodium chloride (normal saline) injection |
Inclusion Criteria: * Healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiogram (ECG), and vital signs. * Body weight within 50 to 100 kilograms (kg) (inclusive) and body mass index within 18 to 32 kg/square meter (m\^2) (inclus...
mRNA-0184 is an investigational drug being developed for chronic heart failure and is also being studied in healthy participants to evaluate its safety and tolerability. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
mRNA-0184 targets relaxin, a hormone involved in cardiovascular regulation. By targeting relaxin, the drug is being investigated for its potential role in treating chronic heart failure. The exact mechanism of action is still under evaluation in clinical trials.
mRNA-0184 is being developed by Moderna, Inc., a biotechnology company publicly traded under the ticker symbol MRNA on the NASDAQ stock exchange. Moderna is conducting Phase 1 clinical trials to evaluate the safety and tolerability of this investigational drug.
mRNA-0184 is in Phase 1 clinical development. It is an investigational drug that has not yet been approved by the FDA or other regulatory agencies. The ongoing and completed trials are focused on assessing safety, tolerability, and different administration conditions in healthy participants and those with heart failure.
mRNA-0184 has been studied in three Phase 1 trials. NCT05659264 evaluated safety in participants with chronic heart failure and is completed. NCT06243770 and NCT06655870 investigated safety and tolerability in healthy participants under different infusion conditions and subcutaneous administration, respectively. The latter is active but not recruiting.
No, mRNA-0184 is not the same as relaxin. mRNA-0184 is an investigational drug that targets the hormone relaxin. It is being developed to potentially treat chronic heart failure by modulating relaxin-related pathways, but it is a distinct therapeutic agent under clinical investigation.