About this trial
The purpose of this study is to test the safety of mRNA-0184 in healthy participants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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 (m²) (inclusive) at Screening.
Participant who could become pregnant must meet conditions as defined in the protocol.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
mRNA-0184
DrugSC injection
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
Serum Concentrations of Study Drug
Maximum Observed Plasma 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
Sponsors and contacts
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