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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: mRNA-0184

• Study Type: Interventional
• Enrollment (Actual): 44
• 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:

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.

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

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: mRNA-0184 Dose Level A; 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.	Drug: mRNA-0184; Intravenous infusion
Experimental: Cohort 2: mRNA-0184 Dose Level B; 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.	Drug: mRNA-0184; Intravenous infusion
Experimental: Cohort 3: mRNA-0184 Dose Level C; 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.	Drug: mRNA-0184; Intravenous infusion
Experimental: Cohort 4: mRNA-0184 Dose Level D; 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.	Drug: mRNA-0184; Intravenous infusion
Experimental: Cohort 5: mRNA-0184 Dose Level E; 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.	Drug: mRNA-0184; Intravenous infusion
Experimental: Cohort 6: mRNA-0184 Dose Level F; 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.	Drug: mRNA-0184; Intravenous infusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ModernaTX, Inc.
• Investigators: Principal Investigator: Sam L Francis, MBBS MTrauma PhD DPM, Nucleus Network

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2024
• Primary Completion (Actual): June 12, 2025
• Study Completion (Actual): June 12, 2025

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): February 6, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Moderna; Messenger RNA; mRNA-0184
• Other Study ID Numbers: mRNA-CRTX-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes