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The purpose of this study is to evaluate the safety and tolerability of intravenously (IV) administered mRNA-0184 under different infusion conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-0184 | Drug | Intravenous infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Day 1 through Day 57 | |
| Number of Participants with Adverse Events of Special Interest (AESIs) | Day 1 through Day 57 | |
| Number of Participants with Serious Adverse Events (SAEs) | Day 1 through Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentrations of Study Drug | Day 1 through Day 57 | |
| Maximum Concentration (Cmax) of Study Drug | Day 1 through Day 57 | |
| Area Under the Concentration-time Curve from Time 0 to Last Quantifiable Concentration (AUC0-t) of Study Drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Melbourne | Victoria | 3004 | Australia |
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| 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. |
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| 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. |
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| Day 1 through Day 57 |
| Serum Concentrations of Relaxin-2-variable Light Chain Kappa (Rel2- vlk) Protein | Day 1 through Day 57 |
| Maximum Observed Response (Emax) of Rel2- vlk Protein | Day 1 through Day 57 |
| Area Under the Effect-time Curve (AUEC) of Rel2- vlk Protein | Day 1 through Day 57 |
| Number of Participants with Anti-Polyethylene Glycol (PEG) Antibodies | Day 1 through Day 57 |
| Number of Participants with Anti-Rel2-vlk Protein Antibodies | Day 1 through Day 57 |