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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06243770




Registration number
NCT06243770
Ethics application status
Date submitted
29/01/2024
Date registered
6/02/2024
Date last updated
15/04/2024

Titles & IDs
Public title
Study to Investigate Safety and Tolerability of mRNA-0184 Administered at 2 Different Infusion Durations in Healthy Participants
Scientific title
A Phase 1, Randomized, Open-label, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-0184 Administered at 2 Different Infusion Durations in Healthy Participants
Secondary ID [1] 0 0
mRNA-CRTX-001
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: Sequence 1: mRNA-0184 - Participants will receive infusion duration 1 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion duration 2 of mRNA-0184 on Day 22.

Experimental: Sequence 2: mRNA-0184 - Participants will receive infusion duration 2 of mRNA-0184 on Day 1, followed by a washout period of approximately 21 days. They will then receive infusion duration 1 of mRNA-0184 on Day 22.


Treatment: Drugs: mRNA-0184
Intravenous infusion
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)
Timepoint [1] 0 0
Day 1 through Day 57
Primary outcome [2] 0 0
Number of Participants with Adverse Events of Special Interest (AESIs)
Timepoint [2] 0 0
Day 1 through Day 57
Primary outcome [3] 0 0
Number of Participants with Serious Adverse Events (SAEs)
Timepoint [3] 0 0
Day 1 through Day 57
Secondary outcome [1] 0 0
Serum Concentrations of Study Drug
Timepoint [1] 0 0
Day 1 through Day 57
Secondary outcome [2] 0 0
Maximum Concentration (Cmax) of Study Drug
Timepoint [2] 0 0
Day 1 through Day 57
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 57
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 57
Secondary outcome [5] 0 0
Maximum Observed Response (Emax) of Rel2- vlk Protein
Timepoint [5] 0 0
Day 1 through Day 57
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 57
Secondary outcome [7] 0 0
Number of Participants with Anti-Polyethylene Glycol (PEG) Antibodies
Timepoint [7] 0 0
Day 1 through Day 57
Secondary outcome [8] 0 0
Number of Participants with Anti-Rel2-vlk Protein Antibodies
Timepoint [8] 0 0
Day 1 through Day 57

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

Study design
Purpose of the study
Basic Science
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
16/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
40
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
The purpose of this study is to evaluate the safety and tolerability of intravenously (IV)
administered mRNA-0184 at 2 different infusion durations.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06243770
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sam L Francis, MBBS MTrauma PhD DPM
Address 0 0
Nucleus Network
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
clinicaltrials@modernatx.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06243770