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Recruiting
NCT05659264
A Study to Evaluate the Safety of mRNA-0184 in Participants With Heart Failure
Conditions: Chronic Heart Failure
Sex: All
Ages: 18 Years – N/A
Phase: PHASE1
Enrollment: 98
Sponsor: ModernaTX, Inc.
Location: Poland
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
Key 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.Key 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.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 pulmonary hypertension.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 a COVID-19 vaccination (irrespective of type of vaccine) or is anticipated to require a second dose of a 2-dose COVID-19 vaccine series 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 effective 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.
Source: ClinicalTrials.gov (NCT05659264). StuddyBuddy aggregates publicly available trial information.