Healthy Participants
Conditions
Keywords
mRNA-0184, Messenger RNA, Moderna
Brief summary
The purpose of this study is to evaluate the safety and tolerability of intravenously (IV) administered mRNA-0184 under different infusion conditions.
Interventions
DRUGmRNA-0184
Intravenous infusion
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Serum Concentrations of Study Drug | Day 1 through Day 57 |
| Maximum Concentration (Cmax) of Study Drug | Day 1 through Day 57 |
| Area Under the Effect-time Curve (AUEC) of Rel2- vlk Protein | 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 |
| Area Under the Concentration-time Curve from Time 0 to Last Quantifiable Concentration (AUC0-t) of Study Drug | Day 1 through Day 57 |
| Number of Participants with Anti-Polyethylene Glycol (PEG) Antibodies | Day 1 through Day 57 |
| Number of Participants with Anti-Rel2-vlk Protein Antibodies | Day 1 through Day 57 |
Countries
Australia
Outcome results
None listed