A Study to Evaluate the Safety of mRNA-0184 in Participants With Heart Failure
NCT ID: NCT05659264
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2022-12-05
2024-12-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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SAD Stage: mRNA-0184
Participants will receive a single dose of mRNA-0184.
mRNA-0184
mRNA-0184 dispersion for intravenous (IV) infusion
MAD Stage: mRNA-0184
Participants will receive up to 4 doses of mRNA-0184 administered over a treatment period of up to 16 weeks.
mRNA-0184
mRNA-0184 dispersion for intravenous (IV) infusion
MAD Stage: Placebo
Participants will receive placebo matching to mRNA-0184 administered over a treatment period of up to 16 weeks.
Placebo
0.9% sodium chloride (normal saline) injection
Interventions
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mRNA-0184
mRNA-0184 dispersion for intravenous (IV) infusion
Placebo
0.9% sodium chloride (normal saline) injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
University College Hospital
London, City of London, United Kingdom
Derriford Hospital
Plymouth, Devon, United Kingdom
The Royal Liverpool University Hospital
Liverpool, , United Kingdom
Countries
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Other Identifiers
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2022-000784-46
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
mRNA-0184-P101
Identifier Type: -
Identifier Source: org_study_id
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