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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: mRNA-0184

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Nucleus Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Ascending Dose (SAD): mRNA-0184; Participants will receive a single subcutaneous (SC) injection of a fixed dose of mRNA-0184 on Day 1.	Drug: mRNA-0184; SC injection
Experimental: Multiple Ascending Dose (MAD): mRNA-0184; Participants will receive up to 2 SC injections of a fixed dose of mRNA-0184 on Days 1 and 15.	Drug: mRNA-0184; SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Area Under the Effect-time Curve (AUEC) of of Rel2- vlk Protein	Day 1 through Day 50
Number of Participants with Anti-Polyethylene Glycol (PEG) Antibodies	Day 1 through Day 50
Number of Participants with Anti-Rel2-vlk Protein Antibodies	Day 1 through Day 50

Collaborators and Investigators

• Sponsor: ModernaTX, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2024
• Primary Completion (Estimated): June 23, 2026
• Study Completion (Estimated): June 23, 2026

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Moderna; Messenger RNA; mRNA-0184
• Other Study ID Numbers: mRNA-CRTX-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No