A Study to Investigate Safety and Tolerability of mRNA-0184 Administered Subcutaneously in Healthy Participants

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorModernaTX, Inc.

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • mRNA-0184

    Drug

    SC injection

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Single Ascending Dose (SAD): mRNA-0184Experimental treatment 1 intervention
Group B: Repeat-Dose: mRNA-0184Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Day 1 through Day 50

Secondary outcomes

1

Serum Concentrations of Study Drug

Time frame
Day 1 through Day 50
2

Maximum Observed Plasma Concentration (Cmax) of Study Drug

Time frame
Day 1 through Day 50
3

Area Under the Concentration-time Curve from Time 0 to Last Quantifiable Concentration (AUC0-t) of Study Drug

Time frame
Day 1 through Day 50
4

Serum Concentrations of Relaxin-2-variable Light Chain Kappa (Rel2- vlk) Protein

Time frame
Day 1 through Day 50

Other outcomes

Sponsors and contacts

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