NCT05659264CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 17 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 13 Dec 2022
- Start date
- 5 Dec 2022
- Primary completion date
- 17 Dec 2024
- Lead sponsor
- ModernaTX, Inc.
- Diseases
- Heart failure
- NCT number
- NCT05659264
- EudraCT number
- 2022-000784-46
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 48
- From 5 Dec 2022 to the primary completion date, 17 Dec 2024
- 14 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Hospitalized for cardiovascular causes within 3 months before Screening.
- Decompensated HF, acute myocarditis, hypertrophic and/or restrictive/constrictive cardiomyopathy, or moderate or severe valvular heart disease (as classified by echocardiography) at Screening or within the 3 months before Screening. Moderate tricuspid regurgitation is not exclusionary. Congenital heart disease as the primary etiology for heart failure will be excluded.
- History of hypersensitivity to any components of the investigational product (IP).
- Participant has received or is expected to receive a COVID-19 vaccination within 7 days of the planned date of IP administration.
- Participation in another clinical study of another IP within 30 days before Screening or within 5 terminal elimination half-lives of the IP, whichever is longer.
Other illness
- Symptoms of angina pectoris at Screening.
- Severe obstructive or restrictive pulmonary pathology, including chronic obstructive pulmonary disease Gold Stage III or IV, current use of oxygen therapy, or Group 1, 3, 4, or 5 pulmonary hypertension. Group 2 pulmonary hypertension is not exclusionary.
- History of sustained ventricular tachycardia or atrial fibrillation/atrial flutter with a ventricular response ≥ 110 beats per minute (bpm) at the time of Screening.
- Any other clinically significant medical condition that, in the Investigator's opinion, could interfere with the interpretation of study results or limit the participant's participation in the study, including poorly controlled diabetes mellitus.
Other
- For SAD cohort participants to be rolled over into the MAD stage, have experienced a dose-limiting toxicity (DLT) in a SAD cohort.
Who the study is looking for
- Documented diagnosis of heart failure (HF) based on medical records.
- Left ventricular ejection fraction (LVEF) ≥ 35% and \< 50% at Screening, or documented within the 3 months before Screening, measured by transthoracic echocardiogram (TTE) or cardiac magnetic resonance imaging (MRI).
- New York Heart Association (NYHA) HF Class I or II.
- On a stable regimen of cardiovascular medication(s) for a duration of at least 4 weeks before Screening.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Addenbrooke's Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Ninewells Hospital & Medical School Coordinator of this site? Confirm its status | Dundee | United Kingdom | Unknown status |
| The Royal Liverpool University Hospital Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| University College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Derriford Hospital Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slasiego Uniwersytetu Medycznego w Katowicach Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| Cardiology, PC Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| University of Alabama at Birmingham: The Kirklin Clinic Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Jacksonville Center For Clinical Research - ERN - PPDS Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Tennessee Center for Clinical Trials Coordinator of this site? Confirm its status | Tullahoma | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.