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

NCT06243770 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: mRNA-CRTX-001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of intravenously (IV) administered mRNA-0184 under different infusion conditions.

Conditions

Healthy Participants

Keywords

mRNA-0184; Messenger RNA; Moderna

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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

Study Arms (6)

Cohort 1: mRNA-0184 Dose Level A

EXPERIMENTAL

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

Cohort 2: mRNA-0184 Dose Level B

EXPERIMENTAL

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

Cohort 3: mRNA-0184 Dose Level C

EXPERIMENTAL

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

Cohort 4: mRNA-0184 Dose Level D

EXPERIMENTAL

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

Cohort 5: mRNA-0184 Dose Level E

EXPERIMENTAL

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

Cohort 6: mRNA-0184 Dose Level F

EXPERIMENTAL

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

Interventions

mRNA-0184 DRUG

Intravenous infusion

Cohort 1: mRNA-0184 Dose Level A; Cohort 2: mRNA-0184 Dose Level B; Cohort 3: mRNA-0184 Dose Level C; Cohort 4: mRNA-0184 Dose Level D; Cohort 5: mRNA-0184 Dose Level E; Cohort 6: mRNA-0184 Dose Level F

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.
• 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 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 investigational product (IP) (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 on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
• 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.
• 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.

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: January 29, 2024
• First Posted: February 6, 2024
• Study Start: February 16, 2024
• Primary Completion: June 12, 2025
• Study Completion: June 12, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

AU (1)