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A Study to Evaluate the Safety of mRNA-0184 in Participants With Heart Failure | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT05659264•ModernaTX, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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.
•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.
•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.
•For SAD cohort participants to be rolled over into the MAD stage, have experienced a dose-limiting toxicity (DLT) in a SAD cohort.
•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.
•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.

Locations (14)

Cardiology PC

Birmingham, Alabama, United States

University of Alabama at Birmingham: The Kirklin Clinic

Birmingham, Alabama, United States

University of Florida

Gainesville, Florida, United States

Jacksonville Center For Clinical Research - ERN - PPDS

Jacksonville, Florida, United States

Tennessee Center for Clinical Trials

Tullahoma, Tennessee, United States

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Greater Poland Voivodeship, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, Lower Silesian Voivodeship, Poland

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Podlaskie Voivodeship, Poland

Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slasiego Uniwersytetu Medycznego w Katowicach

Katowice, Silesian Voivodeship, Poland

Ninewells Hospital & Medical School

Dundee, Angus, United Kingdom

Key Dates

Start Date

December 5, 2022

Primary Completion Date

December 17, 2024

Completion Date

December 17, 2024

Last Updated

March 17, 2025

Enrollment

ACTUAL participants

Conditions

Chronic Heart Failure

Interventions

mRNA-0184

DRUG

Placebo

DRUG

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Mindful Steps 2.0: Promoting Physical Activity in Patients With COPD and HF

NCT05934565

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Evaluate the Safety of mRNA-0184 in Participants With Heart Failure

Inclusion Criteria

Exclusion Criteria

Impact of YOGA on the Quality of Life and Well-being of Heart Failure Patients

Effectiveness of Low -Versus High -Volume High -Intensity Interval Training in Patients With Chronic Heart Failure

Mindful Steps 2.0: Promoting Physical Activity in Patients With COPD and HF

Effect of Empagliflozin on Quality of Life in Chronic Heart Failure Patients With Diabetes Mellitus Type II

Acetazolamide Per os for Decompensation of Heart Failure

A Holistic Patient-centred Intervention to Improve Outcomes of Older People Living With Frailty and Chronic Heart Failure