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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000784-46 | EudraCT Number |
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The primary objective of this study is to evaluate the safety and tolerability of single and multiple doses at escalating dose levels of mRNA-0184.
The study includes a SAD stage and MAD stage; the stages of SAD and MAD may overlap. The SAD stage will begin first, and data from this stage will inform decisions about dose levels in subsequent SAD cohorts and in the MAD stage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD Stage: mRNA-0184 | Experimental | Participants will receive a single dose of mRNA-0184. |
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| 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. |
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| MAD Stage: Placebo | Placebo Comparator | Participants will receive placebo matching to mRNA-0184 administered over a treatment period of up to 16 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-0184 | Drug | mRNA-0184 dispersion for intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Baseline up to Day 296 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentrations of mRNA Encoding Relaxin-2-variable Light Chain Kappa (Rel2- vlk mRNA) | Day 1 (within 60 minutes predose) up to Day 183 | |
| Maximum Observed Plasma Concentration (Cmax) of Rel2-vlk mRNA | Day 1 (within 60 minutes predose) up to Day 183 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology PC | Birmingham | Alabama | 35211 | United States | ||
| University of Alabama at Birmingham: The Kirklin Clinic |
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The single ascending dose (SAD) stage of this study is open-label and the multiple ascending dose (MAD) stage of this study is single-blind and placebo-controlled.
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| Placebo | Drug | 0.9% sodium chloride (normal saline) injection |
|
| Area Under the Curve From Time 0 to Time t (AUC0-t) of Rel2-vlk mRNA | Day 1 (within 60 minutes predose) up to Day 183 |
| Serum Concentrations of Relaxin-2-variable Light Chain Kappa (Rel2- vlk) Protein | Day 1 (within 60 minutes predose) up to Day 183 |
| Maximum Observed Effect (Emax) of Rel2- vlk Protein | Day 1 (within 60 minutes predose) up to Day 183 |
| Area Under the Effect-Time Curve (AUEC) of Rel2-vlk Protein | Day 1 (within 60 minutes predose) up to Day 183 |
| Number of Participants With Anti-polyethylene glycol (PEG) Antibodies | Baseline up to Day 183 |
| Number of Participants With anti-Rel2-vlk Protein Antibodies | Baseline up to Day 183 |
| Birmingham |
| Alabama |
| 35233 |
| United States |
| University of Florida | Gainesville | Florida | 32608 | United States |
| Jacksonville Center For Clinical Research - ERN - PPDS | Jacksonville | Florida | 32216 | United States |
| Tennessee Center for Clinical Trials | Tullahoma | Tennessee | 37388 | United States |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Poznan | Greater Poland Voivodeship | 61-848 | Poland |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu | Wroclaw | Lower Silesian Voivodeship | 50-556 | Poland |
| Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | Podlaskie Voivodeship | 15-276 | Poland |
| Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slasiego Uniwersytetu Medycznego w Katowicach | Katowice | Silesian Voivodeship | 40-635 | Poland |
| Ninewells Hospital & Medical School | Dundee | Angus | DD1 9SY | United Kingdom |
| Addenbrooke's Hospital | Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
| University College Hospital | London | City of London | NW1 2BU | United Kingdom |
| Derriford Hospital | Plymouth | Devon | PL6 8DH | United Kingdom |
| The Royal Liverpool University Hospital | Liverpool | L7 8XP | United Kingdom |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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