Chronic Heart FailurePhase 1NCT05659264
A Study to Evaluate the Safety of mRNA-0184 in Participants With Heart Failure
A Phase 1 study testing mRNA-0184 in people with Chronic Heart Failure, run by ModernaTX, Inc. at 14 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- mRNA-0184
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 5 Dec 2022to 17 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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. 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).
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- 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.
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
United States5 sites
Cardiology PC
Birmingham, Alabama, 35211
University of Alabama at Birmingham: The Kirklin Clinic
Birmingham, Alabama, 35233
University of Florida
Gainesville, Florida, 32608
Jacksonville Center For Clinical Research - ERN - PPDS
Jacksonville, Florida, 32216
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, 37388
United Kingdom5 sites
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ
Ninewells Hospital & Medical School
Dundee, Angus, DD1 9SY
The Royal Liverpool University Hospital
Liverpool, L7 8XP
University College Hospital
London, City of London, NW1 2BU
Derriford Hospital
Plymouth, Devon, PL6 8DH
Poland4 sites
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Podlaskie Voivodeship, 15-276
Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slasiego Uniwersytetu Medycznego w Katowicach
Katowice, Silesian Voivodeship, 40-635
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Greater Poland Voivodeship, 61-848
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, 50-556
About this study
Official title: A Phase 1, Adaptive, Open-Label, Single Ascending Dose to Single-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-0184 in Participants With Chronic Heart Failure
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.
Read the detailed 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.
- Conditions
- Chronic Heart Failure
- Being tested
- mRNA-0184, Placebo
- Keywords
- Single ascending dose, Multiple ascending dose, mRNA-0184, Heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-0184Drug
mRNA-0184 dispersion for intravenous (IV) infusion
PlaceboDrug
0.9% sodium chloride (normal saline) injection
| Study group | Role | What they receive |
|---|---|---|
| SAD Stage: mRNA-0184 | Experimental | Participants will receive a single dose of mRNA-0184. Receives: Drug: mRNA-0184 |
| MAD Stage: mRNA-0184 | Experimental | Participants will receive up to 4 doses of mRNA-0184 administered over a treatment period of up to 16 weeks. Receives: Drug: mRNA-0184 |
| MAD Stage: Placebo | Placebo comparator | Participants will receive placebo matching to mRNA-0184 administered over a treatment period of up to 16 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Measured: Baseline up to Day 296
Secondary outcomes (8)
Serum Concentrations of mRNA Encoding Relaxin-2-variable Light Chain Kappa (Rel2- vlk mRNA)
Measured: Day 1 (within 60 minutes predose) up to Day 183
Maximum Observed Plasma Concentration (Cmax) of Rel2-vlk mRNA
Measured: Day 1 (within 60 minutes predose) up to Day 183
Area Under the Curve From Time 0 to Time t (AUC0-t) of Rel2-vlk mRNA
Measured: Day 1 (within 60 minutes predose) up to Day 183
Serum Concentrations of Relaxin-2-variable Light Chain Kappa (Rel2- vlk) Protein
Measured: Day 1 (within 60 minutes predose) up to Day 183
Maximum Observed Effect (Emax) of Rel2- vlk Protein
Measured: Day 1 (within 60 minutes predose) up to Day 183
Area Under the Effect-Time Curve (AUEC) of Rel2-vlk Protein
Measured: Day 1 (within 60 minutes predose) up to Day 183
Number of Participants With Anti-polyethylene glycol (PEG) Antibodies
Measured: Baseline up to Day 183
Number of Participants With anti-Rel2-vlk Protein Antibodies
Measured: Baseline up to Day 183
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start5 Dec 2022
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The single ascending dose (SAD) stage of this study is open-label and the multiple ascending dose (MAD) stage of this study is single-blind and placebo-controlled.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659264
- Sponsor's protocol ID
- mRNA-0184-P101
- Other IDs
- 2022-000784-46
- Status last verified
- Mar 2025
- First submitted
- 13 Dec 2022
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kaushal N, Attarwala H, Iqbal MJ, Saini R, Van L, Liang M. Translational pharmacokinetic/pharmacodynamic model for mRNA-0184, an investigational therapeutic for the treatment of heart failure. Clin Transl Sci. 2024 Aug;17(8):e13894. doi: 10.1111/cts.13894.
PubMed 39072952
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Adaptive, Open-Label, Single Ascending Dose to Single-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-0184 in Participants With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT05659264
- Acronym / sponsor ID
- mRNA-0184-P101
- Conditions
- Chronic Heart Failure
- Keywords
- Single ascending dose, Multiple ascending dose, mRNA-0184, Heart failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The single ascending dose (SAD) stage of this study is open-label and the multiple ascending dose (MAD) stage of this study is single-blind and placebo-controlled.
| Arm | Type | Receives |
|---|---|---|
| SAD Stage: mRNA-0184 | Experimental | Drug: mRNA-0184Participants will receive a single dose of mRNA-0184. |
| MAD Stage: mRNA-0184 | Experimental | Drug: mRNA-0184Participants will receive up to 4 doses of mRNA-0184 administered over a treatment period of up to 16 weeks. |
| MAD Stage: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo matching to mRNA-0184 administered over a treatment period of up to 16 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (10 listed)
- 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. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-0184mRNA-0184 dispersion for intravenous (IV) infusion | Drug | MAD Stage: mRNA-0184, SAD Stage: mRNA-0184 |
| Placebo0.9% sodium chloride (normal saline) injection | Drug | MAD Stage: Placebo |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 296
8 secondary outcomes
Serum Concentrations of mRNA Encoding Relaxin-2-variable Light Chain Kappa (Rel2- vlk mRNA)
Time frame: Day 1 (within 60 minutes predose) up to Day 183
Maximum Observed Plasma Concentration (Cmax) of Rel2-vlk mRNA
Time frame: Day 1 (within 60 minutes predose) up to Day 183
Area Under the Curve From Time 0 to Time t (AUC0-t) of Rel2-vlk mRNA
Time frame: Day 1 (within 60 minutes predose) up to Day 183
Serum Concentrations of Relaxin-2-variable Light Chain Kappa (Rel2- vlk) Protein
Time frame: Day 1 (within 60 minutes predose) up to Day 183
Maximum Observed Effect (Emax) of Rel2- vlk Protein
Time frame: Day 1 (within 60 minutes predose) up to Day 183
Area Under the Effect-Time Curve (AUEC) of Rel2-vlk Protein
Time frame: Day 1 (within 60 minutes predose) up to Day 183
Number of Participants With Anti-polyethylene glycol (PEG) Antibodies
Time frame: Baseline up to Day 183
Number of Participants With anti-Rel2-vlk Protein Antibodies
Time frame: Baseline up to Day 183
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Derived from this study: PubMed 39072952Kaushal N, Attarwala H, Iqbal MJ, Saini R, Van L, Liang M. Translational pharmacokinetic/pharmacodynamic model for mRNA-0184, an investigational therapeutic for the treatment of heart failure. Clin Transl Sci. 2024 Aug;17(8):e13894. doi: 10.1111/cts.13894.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mRNA-0184 in people with Chronic Heart Failure, run by ModernaTX, Inc. at 14 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, United Kingdom, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Baseline up to Day 296). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05659264, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.