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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06655870 | A Study to Investigate Safety and Tolerability of mRNA-0184 Administered Subcutaneously in Healthy Participants | PHASE1 | ACTIVE NOT_RECRUITING | 52 | — | — | Oct 31, 2024 | Jun 23, 2026 | Jan 20, 2026 | 1 | Australia |
| NCT06243770 | Study to Investigate Safety and Tolerability of mRNA-0184 Administered Under Different Infusion Conditions in Healthy Participants | PHASE1 | COMPLETED | 44 | — | — | Feb 16, 2024 | Jun 12, 2025 | Aug 1, 2025 | 1 | Australia |
| 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. |
| Name | Type | Description |
|---|---|---|
| mRNA-0184 | DRUG | SC 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...