Study to Investigate Safety and Tolerability of mRNA-0184 Administered Under Different Infusion Conditions in Healthy Participants
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 Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3004
- Nucleus Network
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiogram (ECG), and vital signs.
- Participant who could become pregnant must meet conditions as defined in the protocol.
Exclusion Criteria:
- 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.
- Any clinically significant illness, or medical/surgical procedure, within 4 weeks of the first administration of the study investigational product (IP) (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 on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cohort 1: mRNA-0184 Dose Level A
Sequence 1: Participants will receive infusion condition 1 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 2 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 2 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 1 of mRNA-0184 on Day 22. |
Intravenous infusion
|
|
Experimental: Cohort 2: mRNA-0184 Dose Level B
Sequence 1: Participants will receive infusion condition 1 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 2 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 2 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 1 of mRNA-0184 on Day 22. |
Intravenous infusion
|
|
Experimental: Cohort 3: mRNA-0184 Dose Level C
Sequence 1: Participants will receive infusion condition 1 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 2 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 2 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 1 of mRNA-0184 on Day 22. |
Intravenous infusion
|
|
Experimental: Cohort 4: mRNA-0184 Dose Level D
Sequence 1: Participants will receive infusion condition 3 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 4 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 4 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 3 of mRNA-0184 on Day 22. |
Intravenous infusion
|
|
Experimental: Cohort 5: mRNA-0184 Dose Level E
Sequence 1: Participants will receive infusion condition 5 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 6 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 6 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 5 of mRNA-0184 on Day 22. |
Intravenous infusion
|
|
Experimental: Cohort 6: mRNA-0184 Dose Level F
Sequence 1: Participants will receive infusion condition 5 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 6 of mRNA-0184 on Day 22. Sequence 2: Participants will receive infusion condition 6 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion condition 5 of mRNA-0184 on Day 22. |
Intravenous infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Day 1 through Day 57
|
Day 1 through Day 57
|
|
Number of Participants with Adverse Events of Special Interest (AESIs)
Time Frame: Day 1 through Day 57
|
Day 1 through Day 57
|
|
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: Day 1 through Day 57
|
Day 1 through Day 57
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Serum Concentrations of Study Drug
Time Frame: Day 1 through Day 57
|
Day 1 through Day 57
|
|
Maximum Concentration (Cmax) of Study Drug
Time Frame: Day 1 through Day 57
|
Day 1 through Day 57
|
|
Area Under the Concentration-time Curve from Time 0 to Last Quantifiable Concentration (AUC0-t) of Study Drug
Time Frame: Day 1 through Day 57
|
Day 1 through Day 57
|
|
Serum Concentrations of Relaxin-2-variable Light Chain Kappa (Rel2- vlk) Protein
Time Frame: Day 1 through Day 57
|
Day 1 through Day 57
|
|
Maximum Observed Response (Emax) of Rel2- vlk Protein
Time Frame: Day 1 through Day 57
|
Day 1 through Day 57
|
|
Number of Participants with Anti-Polyethylene Glycol (PEG) Antibodies
Time Frame: Day 1 through Day 57
|
Day 1 through Day 57
|
|
Number of Participants with Anti-Rel2-vlk Protein Antibodies
Time Frame: Day 1 through Day 57
|
Day 1 through Day 57
|
|
Area Under the Effect-time Curve (AUEC) of Rel2- vlk Protein
Time Frame: Day 1 through Day 57
|
Day 1 through Day 57
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sam L Francis, MBBS MTrauma PhD DPM, Nucleus Network
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- mRNA-CRTX-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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