Testing the safety of mRNA-0184 in healthy participants

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

This study is testing a new mRNA treatment called mRNA-0184 to see if it's safe for healthy people.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: ModernaTX, Inc. (industry)
• Locations: 1 site (Melbourne, Victoria)
• Trial ID: NCT06655870 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and tolerability of mRNA-0184, an mRNA-based treatment, administered subcutaneously to healthy participants. The trial is designed to evaluate the participants' health through medical evaluations, including medical history, physical examinations, and laboratory tests. The study aims to gather data on the safety profile of the treatment, which is crucial for future applications in broader populations.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy individuals aged 18 to 65 with a body weight between 50 to 100 kg and a BMI of 18 to 32.

Not a fit: Patients with significant medical histories or conditions that could affect their participation or the study's outcomes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the safety of mRNA-0184, paving the way for its use in treating various conditions.

How similar studies have performed: Other studies involving mRNA treatments have shown promising results, indicating a potential for success in this novel approach.

Eligibility criteria

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.

Where this trial is running

Melbourne, Victoria

• Nucleus Network — Melbourne, Victoria, Australia (RECRUITING)

Study contacts

• Study coordinator: Moderna WeCare Team

Conditions: Healthy Participants, mRNA-0184, Messenger RNA, Moderna