Clinical trial NCT06243770: Study to Investigate Safety and Tolerability of mRNA-0184 Administered Under Different Infusion Conditions in Healthy Participants
Official title: A Phase 1, Randomized, Open-label, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-0184 Administered Under Different Infusion Conditions 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: 2024-02-06
Enrollment: 48
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 evaluate the safety and tolerability of intravenously (IV) administered mRNA-0184 under different infusion conditions.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Day 1 through Day 57
measure: Number of Participants with Adverse Events of Special Interest (AESIs)
timeFrame: Day 1 through Day 57
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Day 1 through Day 57
Secondary outcomes:
measure: Serum Concentrations of Study Drug
timeFrame: Day 1 through Day 57
measure: Maximum Concentration (Cmax) of Study Drug
timeFrame: Day 1 through Day 57
measure: Area Under the Concentration-time Curve from Time 0 to Last Quantifiable Concentration (AUC0-t) of Study Drug
timeFrame: Day 1 through Day 57
measure: Serum Concentrations of Relaxin-2-variable Light Chain Kappa (Rel2- vlk) Protein
timeFrame: Day 1 through Day 57
measure: Maximum Observed Response (Emax) of Rel2- vlk Protein
timeFrame: Day 1 through Day 57
measure: Area Under the Effect-time Curve (AUEC) of Rel2- vlk Protein
timeFrame: Day 1 through Day 57
measure: Number of Participants with Anti-Polyethylene Glycol (PEG) Antibodies
timeFrame: Day 1 through Day 57
measure: Number of Participants with Anti-Rel2-vlk Protein Antibodies
timeFrame: Day 1 through Day 57
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network
state: Victoria
Study officials:
References: