Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to test the safety of mRNA-0184 in healthy participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-0184 | Drug | SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) Including Injection Site Reactions (ISRs), Adverse Events of Special Interests (AESIs), and Serious Adverse Events (SAEs) | Day 1 through Day 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentrations of Study Drug | Day 1 through Day 50 | |
| Maximum Observed Plasma Concentration (Cmax) of Study Drug | Day 1 through Day 50 | |
| Area Under the Concentration-time Curve from Time 0 to Last Quantifiable Concentration (AUC0-t) of Study Drug |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Melbourne | Victoria | 3004 | Australia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Day 1 through Day 50 |
| Serum Concentrations of Relaxin-2-variable Light Chain Kappa (Rel2- vlk) Protein | Day 1 through Day 50 |
| Maximum Observed Response (Emax) of Rel2- vlk Protein | Day 1 through Day 50 |
| Area Under the Effect-time Curve (AUEC) of of Rel2- vlk Protein | Day 1 through Day 50 |
| Number of Participants with Anti-Polyethylene Glycol (PEG) Antibodies | Day 1 through Day 50 |
| Number of Participants with Anti-Rel2-vlk Protein Antibodies | Day 1 through Day 50 |