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

• Status: Recruiting
• Trial end date: 2024-05-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ModernaTX, Inc.

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.