Evaluating the safety of mRNA-0184 in healthy individuals
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
PHASE1 · ModernaTX, Inc. · NCT06243770
This study is testing the safety of a new mRNA treatment called mRNA-0184 in healthy people to see how different ways of giving it affect how well they tolerate it.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | ModernaTX, Inc. (industry) |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT06243770 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and tolerability of mRNA-0184, an mRNA-based therapeutic, administered intravenously under various infusion conditions. Healthy participants will undergo medical evaluations, including medical history, physical examinations, and laboratory tests, to ensure they meet the inclusion criteria. The study aims to gather data on how different infusion conditions affect the safety profile of the treatment. The findings will contribute to understanding the potential of mRNA therapies in clinical applications.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals who meet specific medical evaluation criteria.
Not a fit: Patients with a history of significant diseases or disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety profile of mRNA therapies, paving the way for their use in various medical conditions.
How similar studies have performed: While mRNA therapies are a novel approach, this specific investigation into infusion conditions is relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiogram (ECG), and vital signs. 2. Participant who could become pregnant must meet conditions as defined in the protocol. Exclusion Criteria: 1. 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. 2. Any clinically significant illness, or medical/surgical procedure, within 4 weeks of the first administration of the study investigational product (IP) (mRNA-0184). 3. 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. 4. Clinically significant abnormal findings in vital signs at Screening. 5. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody. 6. 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. 7. 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.
Where this trial is running
Melbourne, Victoria
- Nucleus Network — Melbourne, Victoria, Australia (RECRUITING)
Study contacts
- Study coordinator: Moderna WeCare Team
- Email: WeCareClinicalTrials@modernatx.com
- Phone: +1-866-663-3762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy Participants, mRNA-0184, Messenger RNA, Moderna