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Completed

NCT Number: NCT06243770

Study to Investigate Safety and Tolerability 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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network

Melbourne, Victoria, 3004, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

mRNA-0184

Drug

Intravenous infusion

Primary outcomes

  1. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: Day 1 through Day 57

  2. Number of Participants with Adverse Events of Special Interest (AESIs)

    Time frame: Day 1 through Day 57

  3. Number of Participants with Serious Adverse Events (SAEs)

    Time frame: Day 1 through Day 57

Secondary outcomes

  1. Serum Concentrations of Study Drug

    Time frame: Day 1 through Day 57

  2. Maximum Concentration (Cmax) of Study Drug

    Time frame: Day 1 through Day 57

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

    Time frame: Day 1 through Day 57

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

    Time frame: Day 1 through Day 57

  5. Maximum Observed Response (Emax) of Rel2- vlk Protein

    Time frame: Day 1 through Day 57

  6. Area Under the Effect-time Curve (AUEC) of Rel2- vlk Protein

    Time frame: Day 1 through Day 57

  7. Number of Participants with Anti-Polyethylene Glycol (PEG) Antibodies

    Time frame: Day 1 through Day 57

  8. Number of Participants with Anti-Rel2-vlk Protein Antibodies

    Time frame: Day 1 through Day 57

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2024
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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