Healthy Participants
Conditions
Keywords
mRNA-0184, Messenger RNA, Moderna
Brief summary
The purpose of this study is to test the safety of mRNA-0184 in healthy participants.
Interventions
DRUGmRNA-0184
SC injection
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
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | Day 1 through Day 50 |
Secondary
| Measure | Time frame |
|---|---|
| Serum Concentrations of Study Drug | Day 1 through Day 50 |
| Maximum Observed Plasma Concentration (Cmax) of Study Drug | Day 1 through Day 50 |
| Area Under the Concentration-time Curve from Time 0 to Last Quantifiable Concentration (AUC0-t) of Study Drug | Day 1 through Day 50 |
| Serum Concentrations of Relaxin-2-variable Light Chain Kappa (Rel2- vlk) Protein | Day 1 through Day 50 |
| Maximum Observed Response (Emax) of Rel2- vlk Protein | Day 1 through Day 50 |
| Area Under the Effect-time Curve (AUEC) of Rel2- vlk Protein | Day 1 through Day 50 |
| Number of Participants with Anti-Polyethylene Glycol (PEG) Antibodies | Day 1 through Day 50 |
| Number of Participants with Anti-Rel2-vlk Protein Antibodies | Day 1 through Day 50 |
Countries
Australia
Contacts
CONTACTModerna WeCare Team
Outcome results
None listed