Clinical trial NCT06655870: A Study to Investigate Safety and Tolerability of mRNA-0184 Administered Subcutaneously in Healthy Participants
Official title: A Phase 1, Single-Center, Open-label, Single Ascending Dose and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of mRNA-0184 Administered Subcutaneously in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Participants
Keywords: mRNA-0184
Messenger RNA
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-23
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to test the safety of mRNA-0184 in healthy participants.


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: Day 1 through Day 50
Secondary outcomes:
measure: Serum Concentrations of Study Drug
timeFrame: Day 1 through Day 50
measure: Maximum Observed Plasma Concentration (Cmax) of Study Drug
timeFrame: Day 1 through Day 50
measure: Area Under the Concentration-time Curve from Time 0 to Last Quantifiable Concentration (AUC0-t) of Study Drug
timeFrame: Day 1 through Day 50
measure: Serum Concentrations of Relaxin-2-variable Light Chain Kappa (Rel2- vlk) Protein
timeFrame: Day 1 through Day 50
measure: Maximum Observed Response (Emax) of Rel2- vlk Protein
timeFrame: Day 1 through Day 50
measure: Area Under the Effect-time Curve (AUEC) of of Rel2- vlk Protein
timeFrame: Day 1 through Day 50
measure: Number of Participants with Anti-Polyethylene Glycol (PEG) Antibodies
timeFrame: Day 1 through Day 50
measure: Number of Participants with Anti-Rel2-vlk Protein Antibodies
timeFrame: Day 1 through Day 50
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network
state: Victoria
Study officials:
References: