Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06655870

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

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.
  • 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.

Treatment and study plan

mRNA-0184

Drug

SC injection

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)

    Time frame: Day 1 through Day 50

Secondary outcomes

  1. Serum Concentrations of Study Drug

    Time frame: Day 1 through Day 50

  2. Maximum Observed Plasma Concentration (Cmax) of Study Drug

    Time frame: Day 1 through Day 50

  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 50

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

    Time frame: Day 1 through Day 50

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

    Time frame: Day 1 through Day 50

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

    Time frame: Day 1 through Day 50

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

    Time frame: Day 1 through Day 50

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

    Time frame: Day 1 through Day 50

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2024
Registry last updated
Jan 20, 2026

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.

Published trials that share one or more normalized conditions with this study.