Study to Investigate Safety and Tolerability of mRNA-0184 Administered at 2 Different Infusion Durations in Healthy Participants
- Conditions
- Healthy Participants
- Registration Number
- NCT06243770
- Lead Sponsor
- ModernaTX, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria:<br><br> 1. Healthy as determined by medical evaluation including medical history, physical<br> examination, laboratory tests, electrocardiogram (ECG), and vital signs.<br><br> 2. Participant who could become pregnant must meet conditions as defined in the<br> protocol.<br><br>Exclusion Criteria:<br><br> 1. History of any clinically significant disease or disorder which may either put the<br> participant at risk because of participation in the study or influence the results<br> or the participant's ability to participate in the study.<br><br> 2. Any clinically significant illness, or medical/surgical procedure, within 4 weeks of<br> the first administration of the study investigational product (IP) (mRNA-0184).<br><br> 3. Any clinically significant abnormalities in clinical laboratory results at<br> Screening. Repeat assessments are allowed at the Investigator's discretion if a<br> false positive is suspected.<br><br> 4. Clinically significant abnormal findings in vital signs at Screening.<br><br> 5. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C<br> antibody, and human immunodeficiency virus (HIV) antibody.<br><br> 6. Use of any prescribed medication during the 2 weeks or 5 half-lives of the<br> medication, whichever is longer, prior to the first administration of the study IP.<br> Hormonal contraception is permitted.<br><br> 7. Has received another IP within 4 weeks of the first dosing of the study IP or within<br> 5 terminal half-lives of the IP, whichever is longer.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants with Treatment-emergent Adverse Events (TEAEs);Number of Participants with Adverse Events of Special Interest (AESIs);Number of Participants with Serious Adverse Events (SAEs)
- Secondary Outcome Measures
Name Time Method Serum Concentrations of Study Drug;Maximum Concentration (Cmax) of Study Drug;Area Under the Concentration-time Curve from Time 0 to Last Quantifiable Concentration (AUC0-t) of Study Drug;Serum Concentrations of Relaxin-2-variable Light Chain Kappa (Rel2- vlk) Protein;Maximum Observed Response (Emax) of Rel2- vlk Protein;Area Under the Effect-time Curve (AUEC) of of Rel2- vlk Protein;Number of Participants with Anti-Polyethylene Glycol (PEG) Antibodies;Number of Participants with Anti-Rel2-vlk Protein Antibodies