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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.
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

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Addenbrooke's Hospital
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CambridgeUnited KingdomUnknown status
Ninewells Hospital & Medical School
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DundeeUnited KingdomUnknown status
The Royal Liverpool University Hospital
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LiverpoolUnited KingdomUnknown status
University College Hospital
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LondonUnited KingdomUnknown status
Derriford Hospital
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PlymouthUnited KingdomUnknown status
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandUnknown status
Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slasiego Uniwersytetu Medycznego w Katowicach
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KatowicePolandUnknown status
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandUnknown status
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandUnknown status
Cardiology, PC
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BirminghamUnited StatesUnknown status
University of Alabama at Birmingham: The Kirklin Clinic
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BirminghamUnited StatesUnknown status
University of Florida
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GainesvilleUnited StatesUnknown status
Jacksonville Center For Clinical Research - ERN - PPDS
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JacksonvilleUnited StatesUnknown status
Tennessee Center for Clinical Trials
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TullahomaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.