Moderna begins first human safety tests of new mRNA drug
NCT ID NCT06655870
First seen Jun 25, 2026 · Last updated Sep 16, 2026 · Updated 3 times
Summary
This early-stage trial is testing the safety of a new experimental drug called mRNA-0184 in 52 healthy adults. Participants receive one or more injections of the drug, and researchers monitor for side effects and how the drug moves through the body. Since this is a Phase 1 study, the main goal is to check safety, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mRNA-0184
- What could go wrong
- This is a very early Phase 1 study in only 52 healthy people, so it cannot yet show if the drug works for any disease. The main goal is safety, not effectiveness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiogram (ECG), and vital signs. * Body weight within 50 to 100 kilograms (kg) (inclusive) and body mass index within 18 to 32 kg/square meter (m\^2) (inclusive) at Screening. * Participant who could become pregnant must meet conditions as defined in the protocol. Exclusion Criteria: * History of any clinically significant disease or disorder, including bleeding disorders and wound healing disorders, which may either put the participant at risk because of participation in the study or influence the results or the participant's ability to participate in the study. * Any clinically significant illness, or medical/surgical procedure, within 4 weeks of the first administration of the study drug (mRNA-0184). * Any clinically significant abnormalities in clinical laboratory results at Screening. Repeat assessments are allowed at the Investigator's discretion if a false positive is suspected. * Clinically significant abnormal findings in vital signs at Screening. * Any positive result at Screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus antibody. * Use of any prescribed medication or over-the-counter (OTC) medication that may have an impact on the interpretation of study analyses in the opinion of the Investigator during the 2 weeks or 5 half-lives of the medication, whichever is longer, prior to the first administration of the study drug. Such prescribed or OTC medications are also not permitted during participation in the study. Hormonal contraception is permitted. * Participation in another clinical study of another drug product (DP) within 30 days before Screening or within 5 terminal half-lives of the DP, whichever is longer.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Nucleus Network
RECRUITINGMelbourne, Victoria, 3004, Australia
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