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There are 2 parts to this study: a single ascending dose (single dose of mRNA-6231) part and a multiple ascending dose (repeat doses of mRNA-6231) part. The main goal of this study is to evaluate the safety and tolerability of escalating doses of single and repeat subcutaneous (SC) administration of mRNA-6231. Dose levels of mRNA-6231 are planned to be investigated in a dose-escalation manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-6231 Dose Level 1 | Experimental | In the single dose part of the study (Sentinel and Expansion Cohorts), each participant will receive 1 dose of Dose Level 1 of mRNA-6231 by subcutaneous injection on Day 1. In the repeat dose part of the study (Sentinel and Expansion Cohorts), each participant will receive up to 3 doses of Dose Level 1 of mRNA-6231 once every 2 weeks. |
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| mRNA-6231 Dose Level 2 | Experimental | In the single dose part of the study (Sentinel and Expansion Cohorts), each participant will receive 1 dose of Dose Level 2 of mRNA-6231 by subcutaneous injection on Day 1. In the repeat dose part of the study (Sentinel and Expansion Cohorts), each participant will receive up to 3 doses of Dose Level 2 of mRNA-6231 once every 2 weeks. |
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| mRNA-6231 Dose Level 3 | Experimental | In the single dose part of the study (Sentinel and Expansion Cohorts), each participant will receive 1 dose of Dose Level 3 of mRNA-6231 by subcutaneous injection on Day 1. In the repeat dose part of the study (Sentinel and Expansion Cohorts), each participant will receive up to 3 doses of Dose Level 3 of mRNA-6231 once every 2 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-6231 | Drug | Sterile frozen liquid dispersion for injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) and Serious AEs | Up to Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of mRNA (Serum) and SM-86 (Plasma) | Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29 | |
| Area Under the Concentration-Time Curve (AUC) of mRNA (Serum) and SM-86 (Plasma) | Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Limited | Melbourne | Victoria | 3004 | Australia |
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| Time to Maximum to Observed Effect (TEmax) of mRNA-6231 | Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29 |
| Maximum Observed Effect (Emax) of mRNA-6231 | Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29 |
| Area Under the Effect Versus Time Curve (AUEClast) of mRNA-6231 | Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29 |