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

Last updated: March 14, 2025
Sponsor: ModernaTX, Inc.
Overall Status: Completed

Phase

1

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

Placebo

mRNA-0184

Clinical Study ID

NCT05659264
mRNA-0184-P101
2022-000784-46
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Documented diagnosis of heart failure (HF) based on medical records.

  • Left ventricular ejection fraction (LVEF) ≥ 35% and < 50% at Screening, ordocumented within the 3 months before Screening, measured by transthoracicechocardiogram (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 4weeks before Screening.

Exclusion

Key Exclusion Criteria:

  • Hospitalized for cardiovascular causes within 3 months before Screening.

  • Decompensated HF, acute myocarditis, hypertrophic and/or restrictive/constrictivecardiomyopathy, or moderate or severe valvular heart disease (as classified byechocardiography) at Screening or within the 3 months before Screening. Moderatetricuspid regurgitation is not exclusionary. Congenital heart disease as the primaryetiology for heart failure will be excluded.

  • Symptoms of angina pectoris at Screening.

  • Severe obstructive or restrictive pulmonary pathology, including chronic obstructivepulmonary 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 notexclusionary.

  • History of sustained ventricular tachycardia or atrial fibrillation/atrial flutterwith 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 7days of the planned date of IP administration.

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

  • Participation in another clinical study of another IP within 30 days beforeScreening or within 5 terminal elimination half-lives of the IP, whichever islonger.

  • Any other clinically significant medical condition that, in the Investigator'sopinion, could interfere with the interpretation of study results or limit theparticipant's participation in the study, including poorly controlled diabetesmellitus.

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
December 05, 2022
Estimated Completion Date:
December 17, 2024

Study 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.

Connect with a study center

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw, Dolnoslaskie 50-556
    Poland

    Site Not Available

  • Wojewodzki Specjalistyczny Szpital im Dr Wl Bieganskiego w Lodzi

    Lódz, Lódzkie 91-347
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Opolu

    Opole, Opolskie 45-401
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, Podlaskie 15-276
    Poland

    Site Not Available

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

    Katowice, Slaskie 40-635
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, Wielkopolskie 61-848
    Poland

    Site Not Available

  • Ninewells Hospital & Medical School

    Dundee, Angus DD1 9SY
    United Kingdom

    Site Not Available

  • Addenbrooke's Hospital

    Cambridge, Cambridgeshire CB2 0QQ
    United Kingdom

    Site Not Available

  • University College Hospital

    London, City Of London NW1 2BU
    United Kingdom

    Site Not Available

  • Derriford Hospital

    Plymouth, Devon PL6 8DH
    United Kingdom

    Site Not Available

  • The Royal Liverpool University Hospital

    Liverpool, L7 8XP
    United Kingdom

    Site Not Available

  • Cardiology PC

    Birmingham, Alabama 35211
    United States

    Site Not Available

  • University of Alabama at Birmingham: The Kirklin Clinic

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32608
    United States

    Site Not Available

  • Jacksonville Center For Clinical Research - ERN - PPDS

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Tennessee Center for Clinical Trials

    Tullahoma, Tennessee 37388
    United States

    Site Not Available

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