mRNA-0184 for Heart Failure

Recruiting at 15 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ModernaTX, Inc.

Must be taking: Cardiovascular medications

Disqualifiers: Decompensated HF, Angina, Severe pulmonary disease, others

Compensation: Varies

Number of Visits: Unknown

48 Participants Needed

Trial Summary

What is the purpose of this trial?

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

This trial is for adults with heart failure who have been on stable heart medication for at least 4 weeks. They should have a left ventricular ejection fraction between 35% and <50%, fall under NYHA HF Class I or II, and not be hospitalized for cardiovascular reasons recently. People can't join if they've had recent COVID-19 vaccination, angina symptoms, severe allergies to the drug's components, other clinical study participation recently, uncontrolled diabetes, certain heart diseases or severe lung problems.

Inclusion Criteria

Your heart's pumping function is between 35% and 50%, as measured by a heart imaging test within the past 3 months.

My heart failure is mild to moderate.

I have been officially diagnosed with heart failure.

Exclusion Criteria

History of hypersensitivity to any components of the investigational product (IP)

I was hospitalized for heart-related issues within the last 3 months.

I have had a fast heartbeat due to irregular rhythms in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

SAD Stage

Participants receive a single dose of mRNA-0184

Duration not specified

MAD Stage

Participants receive up to 4 doses of mRNA-0184 or placebo over a treatment period

up to 16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• mRNA-0184
• Placebo

Trial Overview The trial is testing mRNA-0184 against a placebo in people with chronic heart failure. It aims to find out how safe it is and how well participants tolerate different doses of this new treatment when given once or multiple times.

Participant Groups

Group I: SAD Stage: mRNA-0184 Experimental Treatment 1 Intervention

Participants will receive a single dose of mRNA-0184.

Group II: MAD Stage: mRNA-0184 Experimental Treatment 1 Intervention

Participants will receive up to 4 doses of mRNA-0184 administered over a treatment period of up to 16 weeks.

Group III: MAD Stage: Placebo Placebo Group 1 Intervention

Participants will receive placebo matching to mRNA-0184 administered over a treatment period of up to 16 weeks.

Who Is Running the Clinical Trial?

ModernaTX, Inc.

Lead Sponsor

Trials

127

Recruited

66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris