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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06655870




Registration number
NCT06655870
Ethics application status
Date submitted
22/10/2024
Date registered
23/10/2024
Date last updated
29/11/2024

Titles & IDs
Public title
A Study to Investigate Safety and Tolerability of mRNA-0184 Administered Subcutaneously in Healthy Participants
Scientific 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
Secondary ID [1] 0 0
mRNA-CRTX-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Participants 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - mRNA-0184

Experimental: Single Ascending Dose (SAD): mRNA-0184 - Participants will receive a single subcutaneous (SC) injection of a fixed dose of mRNA-0184 on Day 1.

Experimental: Multiple Ascending Dose (MAD): mRNA-0184 - Participants will receive up to 2 SC injections of a fixed dose of mRNA-0184 on Days 1 and 15.


Treatment: Drugs: mRNA-0184
SC injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Day 1 through Day 50
Secondary outcome [1] 0 0
Serum Concentrations of Study Drug
Timepoint [1] 0 0
Day 1 through Day 50
Secondary outcome [2] 0 0
Maximum Observed Plasma Concentration (Cmax) of Study Drug
Timepoint [2] 0 0
Day 1 through Day 50
Secondary outcome [3] 0 0
Area Under the Concentration-time Curve from Time 0 to Last Quantifiable Concentration (AUC0-t) of Study Drug
Timepoint [3] 0 0
Day 1 through Day 50
Secondary outcome [4] 0 0
Serum Concentrations of Relaxin-2-variable Light Chain Kappa (Rel2- vlk) Protein
Timepoint [4] 0 0
Day 1 through Day 50
Secondary outcome [5] 0 0
Maximum Observed Response (Emax) of Rel2- vlk Protein
Timepoint [5] 0 0
Day 1 through Day 50
Secondary outcome [6] 0 0
Area Under the Effect-time Curve (AUEC) of of Rel2- vlk Protein
Timepoint [6] 0 0
Day 1 through Day 50
Secondary outcome [7] 0 0
Number of Participants with Anti-Polyethylene Glycol (PEG) Antibodies
Timepoint [7] 0 0
Day 1 through Day 50
Secondary outcome [8] 0 0
Number of Participants with Anti-Rel2-vlk Protein Antibodies
Timepoint [8] 0 0
Day 1 through Day 50

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/12/2025
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ModernaTX, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Moderna Clinical Trials Support Center
Address 0 0
Country 0 0
Phone 0 0
1-877-777-7187
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06655870