Healthy ParticipantsPhase 1NCT06655870
A Study to Investigate Safety and Tolerability of mRNA-0184 Administered Subcutaneously in Healthy Participants
A Phase 1 study testing mRNA-0184 in people with Healthy Participants, run by ModernaTX, Inc. at 1 site in Australia.
Trial summary
The purpose of this study is to test the safety of mRNA-0184 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- mRNA-0184
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteAustralia
- Study dates
- 31 Oct 2024to 16 Dec 2026
- Phase
- Phase 1
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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Nucleus Network
Melbourne, Victoria, 3004
About this study
Official title: A Phase 1, Single-Center, Open-label, Single Ascending Dose and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of mRNA-0184 Administered Subcutaneously in Healthy Participants
The purpose of this study is to test the safety of mRNA-0184 in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- mRNA-0184
- Keywords
- mRNA-0184, Messenger RNA, Moderna
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-0184Drug
SC injection
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose (SAD): mRNA-0184 | Experimental | Participants will receive a single subcutaneous (SC) injection of a fixed dose of mRNA-0184 on Day 1. Receives: Drug: mRNA-0184 |
| Repeat-Dose: mRNA-0184 | Experimental | Participants will receive up to 2 SC injections of a fixed dose of mRNA-0184 on Days 1 and 15. Receives: Drug: mRNA-0184 |
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) Including Injection Site Reactions (ISRs), Adverse Events of Special Interests (AESIs), and Serious Adverse Events (SAEs)
Measured: Day 1 through Day 50
Secondary outcomes (8)
Serum Concentrations of Study Drug
Measured: Day 1 through Day 50
Maximum Observed Plasma Concentration (Cmax) of Study Drug
Measured: Day 1 through Day 50
Area Under the Concentration-time Curve from Time 0 to Last Quantifiable Concentration (AUC0-t) of Study Drug
Measured: Day 1 through Day 50
Serum Concentrations of Relaxin-2-variable Light Chain Kappa (Rel2- vlk) Protein
Measured: Day 1 through Day 50
Maximum Observed Response (Emax) of Rel2- vlk Protein
Measured: Day 1 through Day 50
Area Under the Effect-time Curve (AUEC) of Rel2- vlk Protein
Measured: Day 1 through Day 50
Number of Participants with Anti-Polyethylene Glycol (PEG) Antibodies
Measured: Day 1 through Day 50
Number of Participants with Anti-Rel2-vlk Protein Antibodies
Measured: Day 1 through Day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start31 Oct 2024
- Primary completion16 Dec 2026 (estimated)
- Study completion16 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655870
- Sponsor's protocol ID
- mRNA-CRTX-002
- Status last verified
- Sep 2026
- First submitted
- 22 Oct 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No