A Study to Investigate Safety and Tolerability of mRNA-0184 Administered Subcutaneously in Healthy Participants

NCT06655870 | Active Not Recruiting Phase 1

• 1 other identifier: mRNA-CRTX-002
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the safety of mRNA-0184 in healthy participants.

Conditions

Healthy Participants

Keywords

mRNA-0184; Messenger RNA; Moderna

Outcome Measures

Primary Outcomes (1)

• 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)

  Day 1 through Day 50

Secondary Outcomes (8)

• Serum Concentrations of Study Drug

  Day 1 through Day 50

• Maximum Observed Plasma Concentration (Cmax) of Study Drug

  Day 1 through Day 50

• Area Under the Concentration-time Curve from Time 0 to Last Quantifiable Concentration (AUC0-t) of Study Drug

  Day 1 through Day 50

• Serum Concentrations of Relaxin-2-variable Light Chain Kappa (Rel2- vlk) Protein

  Day 1 through Day 50

• Maximum Observed Response (Emax) of Rel2- vlk Protein

  Day 1 through Day 50

Study Arms (2)

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.

Drug: mRNA-0184

Multiple Ascending Dose (MAD): mRNA-0184

EXPERIMENTAL

Participants will receive up to 2 SC injections of a fixed dose of mRNA-0184 on Days 1 and 15.

Drug: mRNA-0184

Interventions

mRNA-0184 DRUG

SC injection

Multiple Ascending Dose (MAD): mRNA-0184; Single Ascending Dose (SAD): mRNA-0184

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): June 23, 2026
• Study Completion (Estimated): June 23, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

AU (1)