Trials / Completed
CompletedNCT05659264
A Study to Evaluate the Safety of mRNA-0184 in Participants With Heart Failure
A Phase 1, Adaptive, Open-Label, Single Ascending Dose to Single-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-0184 in Participants With Chronic Heart Failure
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- ModernaTX, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | mRNA-0184 | mRNA-0184 dispersion for intravenous (IV) infusion |
| DRUG | Placebo | 0.9% sodium chloride (normal saline) injection |
Timeline
- Start date
- 2022-12-05
- Primary completion
- 2024-12-17
- Completion
- 2024-12-17
- First posted
- 2022-12-21
- Last updated
- 2025-03-17
Locations
14 sites across 3 countries: United States, Poland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05659264. Inclusion in this directory is not an endorsement.