Study to Investigate Safety and Tolerability of mRNA-0184 Administered at 2 Different Infusion Durations in Healthy Participants

Healthy Participants Clinical Trial

Official title:

A Phase 1, Randomized, Open-label, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-0184 Administered at 2 Different Infusion Durations in Healthy Participants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06243770
• Other study ID #: mRNA-CRTX-001
• Status: Recruiting
• Phase: Phase 1
• Start date: February 16, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: ModernaTX, Inc.
• Contact: Moderna Clinical Trials Support Center
• Phone: 1-877-777-7187
• Email: clinicaltrials[@]modernatx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of intravenously (IV) administered mRNA-0184 at 2 different infusion durations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• mRNA-0184
Intravenous infusion

Locations

Country	Name	City	State
Australia	Nucleus Network	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Treatment-emergent Adverse Events (TEAEs)		Day 1 through Day 57
Primary	Number of Participants with Adverse Events of Special Interest (AESIs)		Day 1 through Day 57
Primary	Number of Participants with Serious Adverse Events (SAEs)		Day 1 through Day 57
Secondary	Serum Concentrations of Study Drug		Day 1 through Day 57
Secondary	Maximum Concentration (Cmax) of Study Drug		Day 1 through Day 57
Secondary	Area Under the Concentration-time Curve from Time 0 to Last Quantifiable Concentration (AUC0-t) of Study Drug		Day 1 through Day 57
Secondary	Serum Concentrations of Relaxin-2-variable Light Chain Kappa (Rel2- vlk) Protein		Day 1 through Day 57
Secondary	Maximum Observed Response (Emax) of Rel2- vlk Protein		Day 1 through Day 57
Secondary	Area Under the Effect-time Curve (AUEC) of of Rel2- vlk Protein		Day 1 through Day 57
Secondary	Number of Participants with Anti-Polyethylene Glycol (PEG) Antibodies		Day 1 through Day 57
Secondary	Number of Participants with Anti-Rel2-vlk Protein Antibodies		Day 1 through Day 57