Healthy ParticipantsPhase 1NCT06243770

Study to Investigate Safety and Tolerability of mRNA-0184 Administered Under Different Infusion Conditions in Healthy Participants

A Phase 1 study testing mRNA-0184 in people with Healthy Participants, run by ModernaTX, Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the safety and tolerability of intravenously (IV) administered mRNA-0184 under different infusion conditions. 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: 44 participants
Where: 1 siteAustralia
Study dates: 16 Feb 2024to 12 Jun 2025
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 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.
Participant who could become pregnant must meet conditions as defined in the protocol.

Who cannot join

History of any clinically significant disease or disorder 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 investigational product (IP) (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 on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
Use of any prescribed medication during the 2 weeks or 5 half-lives of the medication, whichever is longer, prior to the first administration of the study IP. Hormonal contraception is permitted.
Has received another IP within 4 weeks of the first dosing of the study IP or within 5 terminal half-lives of the IP, whichever is longer.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Nucleus Network
Melbourne, Victoria, 3004

Other trials in Australia

About this study

Official title: A Phase 1, Randomized, Open-label, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-0184 Administered Under Different Infusion Conditions in Healthy Participants

The purpose of this study is to evaluate the safety and tolerability of intravenously (IV) administered mRNA-0184 under different infusion conditions.

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
Intravenous infusion

Study groups in NCT06243770
Study group	Role	What they receive
Cohort 1: mRNA-0184 Dose Level A	Experimental	Sequence 1: Participants will receive infusion condition 1 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 2 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 2 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 1 of mRNA-0184 on Day 22. Receives: Drug: mRNA-0184
Cohort 2: mRNA-0184 Dose Level B	Experimental	Sequence 1: Participants will receive infusion condition 1 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 2 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 2 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 1 of mRNA-0184 on Day 22. Receives: Drug: mRNA-0184
Cohort 3: mRNA-0184 Dose Level C	Experimental	Sequence 1: Participants will receive infusion condition 1 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 2 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 2 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 1 of mRNA-0184 on Day 22. Receives: Drug: mRNA-0184
Cohort 4: mRNA-0184 Dose Level D	Experimental	Sequence 1: Participants will receive infusion condition 3 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 4 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 4 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 3 of mRNA-0184 on Day 22. Receives: Drug: mRNA-0184
Cohort 5: mRNA-0184 Dose Level E	Experimental	Sequence 1: Participants will receive infusion condition 5 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 6 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 6 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 5 of mRNA-0184 on Day 22. Receives: Drug: mRNA-0184
Cohort 6: mRNA-0184 Dose Level F	Experimental	Sequence 1: Participants will receive infusion condition 5 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 6 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 6 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 5 of mRNA-0184 on Day 22. 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)
Measured: Day 1 through Day 57
Number of Participants with Adverse Events of Special Interest (AESIs)
Measured: Day 1 through Day 57
Number of Participants with Serious Adverse Events (SAEs)
Measured: Day 1 through Day 57

Secondary outcomes (8)

Serum Concentrations of Study Drug
Measured: Day 1 through Day 57
Maximum Concentration (Cmax) of Study Drug
Measured: Day 1 through Day 57
Area Under the Concentration-time Curve from Time 0 to Last Quantifiable Concentration (AUC0-t) of Study Drug
Measured: Day 1 through Day 57
Serum Concentrations of Relaxin-2-variable Light Chain Kappa (Rel2- vlk) Protein
Measured: Day 1 through Day 57
Maximum Observed Response (Emax) of Rel2- vlk Protein
Measured: Day 1 through Day 57
Area Under the Effect-time Curve (AUEC) of Rel2- vlk Protein
Measured: Day 1 through Day 57
Number of Participants with Anti-Polyethylene Glycol (PEG) Antibodies
Measured: Day 1 through Day 57
Number of Participants with Anti-Rel2-vlk Protein Antibodies
Measured: Day 1 through Day 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Feb 202412 Jun 2025

First posted6 Feb 2024
Study start16 Feb 2024
Primary completion12 Jun 2025
Study completion12 Jun 2025

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: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06243770
Sponsor's protocol ID: mRNA-CRTX-001
Status last verified: Jul 2025
First submitted: 29 Jan 2024
Last updated: 1 Aug 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Open-label, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-0184 Administered Under Different Infusion Conditions in Healthy Participants
ClinicalTrials.gov ID: NCT06243770
Acronym / sponsor ID: mRNA-CRTX-001
Conditions: Healthy Participants
Keywords: mRNA-0184, Messenger RNA, Moderna
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: ModernaTX, Inc.Industry (pharma, biotech, devices)
Study start: 16 Feb 2024 (actual)
Primary completion: 12 Jun 2025 (actual)
Study completion: 12 Jun 2025 (actual)
First posted: 6 Feb 2024 (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 purpose of this study is to evaluate the safety and tolerability of intravenously (IV) administered mRNA-0184 under different infusion conditions.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Cohort 1: mRNA-0184 Dose Level A	Experimental	Drug: mRNA-0184Sequence 1: Participants will receive infusion condition 1 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 2 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 2 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 1 of mRNA-0184 on Day 22.
Cohort 2: mRNA-0184 Dose Level B	Experimental	Drug: mRNA-0184Sequence 1: Participants will receive infusion condition 1 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 2 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 2 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 1 of mRNA-0184 on Day 22.
Cohort 3: mRNA-0184 Dose Level C	Experimental	Drug: mRNA-0184Sequence 1: Participants will receive infusion condition 1 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 2 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 2 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 1 of mRNA-0184 on Day 22.
Cohort 4: mRNA-0184 Dose Level D	Experimental	Drug: mRNA-0184Sequence 1: Participants will receive infusion condition 3 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 4 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 4 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 3 of mRNA-0184 on Day 22.
Cohort 5: mRNA-0184 Dose Level E	Experimental	Drug: mRNA-0184Sequence 1: Participants will receive infusion condition 5 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 6 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 6 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 5 of mRNA-0184 on Day 22.
Cohort 6: mRNA-0184 Dose Level F	Experimental	Drug: mRNA-0184Sequence 1: Participants will receive infusion condition 5 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 6 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 6 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 5 of mRNA-0184 on Day 22.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiogram (ECG), and vital signs.
Participant who could become pregnant must meet conditions as defined in the protocol.

Key exclusion criteria (7 listed)

History of any clinically significant disease or disorder 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 investigational product (IP) (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 on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.

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-0184Intravenous infusion	Drug	Cohort 1: mRNA-0184 Dose Level A, Cohort 2: mRNA-0184 Dose Level B, Cohort 3: mRNA-0184 Dose Level C, Cohort 4: mRNA-0184 Dose Level D, Cohort 5: mRNA-0184 Dose Level E, Cohort 6: mRNA-0184 Dose Level F

Primary outcome

Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 through Day 57
Number of Participants with Adverse Events of Special Interest (AESIs)
Time frame: Day 1 through Day 57
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Day 1 through Day 57

8 secondary outcomes

Serum Concentrations of Study Drug
Time frame: Day 1 through Day 57
Maximum Concentration (Cmax) of Study Drug
Time frame: Day 1 through Day 57
Area Under the Concentration-time Curve from Time 0 to Last Quantifiable Concentration (AUC0-t) of Study Drug
Time frame: Day 1 through Day 57
Serum Concentrations of Relaxin-2-variable Light Chain Kappa (Rel2- vlk) Protein
Time frame: Day 1 through Day 57
Maximum Observed Response (Emax) of Rel2- vlk Protein
Time frame: Day 1 through Day 57
Area Under the Effect-time Curve (AUEC) of Rel2- vlk Protein
Time frame: Day 1 through Day 57
Number of Participants with Anti-Polyethylene Glycol (PEG) Antibodies
Time frame: Day 1 through Day 57
Number of Participants with Anti-Rel2-vlk Protein Antibodies
Time frame: Day 1 through Day 57

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 1 Aug 2025.

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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.

1 site in 1 country: 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 Healthy Participants, run by ModernaTX, Inc. at 1 site in Australia.

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 2 inclusion and 7 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 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. 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. 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: Day 1 through Day 57). The study lists 3 primary outcomes in all. 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 NCT06243770.

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 1 Aug 2025.