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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04916431
Registration number
NCT04916431
Ethics application status
Date submitted
1/06/2021
Date registered
7/06/2021
Date last updated
10/08/2022
Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-6231 in Healthy Adults
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Scientific title
A Phase 1, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-6231, Encoding for a Human Serum Albumin - Interleukin-2 Mutein Fusion Protein (HSA-IL2m), in Healthy Adults
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Secondary ID [1]
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mRNA-6231-P101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - mRNA-6231
Experimental: mRNA-6231 Dose Level 1 - In the single dose part of the study (Sentinel and Expansion Cohorts), each participant will receive 1 dose of Dose Level 1 of mRNA-6231 by subcutaneous injection on Day 1.
In the repeat dose part of the study (Sentinel and Expansion Cohorts), each participant will receive up to 3 doses of Dose Level 1 of mRNA-6231 once every 2 weeks.
Experimental: mRNA-6231 Dose Level 2 - In the single dose part of the study (Sentinel and Expansion Cohorts), each participant will receive 1 dose of Dose Level 2 of mRNA-6231 by subcutaneous injection on Day 1.
In the repeat dose part of the study (Sentinel and Expansion Cohorts), each participant will receive up to 3 doses of Dose Level 2 of mRNA-6231 once every 2 weeks.
Experimental: mRNA-6231 Dose Level 3 - In the single dose part of the study (Sentinel and Expansion Cohorts), each participant will receive 1 dose of Dose Level 3 of mRNA-6231 by subcutaneous injection on Day 1.
In the repeat dose part of the study (Sentinel and Expansion Cohorts), each participant will receive up to 3 doses of Dose Level 3 of mRNA-6231 once every 2 weeks.
Treatment: Drugs: mRNA-6231
Sterile frozen liquid dispersion for injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with Adverse Events (AEs) and Serious AEs
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Assessment method [1]
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Timepoint [1]
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Up to Day 84
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Secondary outcome [1]
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Maximum Observed Concentration (Cmax) of mRNA (Serum) and SM-86 (Plasma)
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Assessment method [1]
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Timepoint [1]
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Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
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Secondary outcome [2]
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Area Under the Concentration-Time Curve (AUC) of mRNA (Serum) and SM-86 (Plasma)
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Assessment method [2]
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Timepoint [2]
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Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
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Secondary outcome [3]
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Time to Maximum to Observed Effect (TEmax) of mRNA-6231
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Assessment method [3]
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Timepoint [3]
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Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
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Secondary outcome [4]
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Maximum Observed Effect (Emax) of mRNA-6231
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Assessment method [4]
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Timepoint [4]
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Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
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Secondary outcome [5]
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Area Under the Effect Versus Time Curve (AUEClast) of mRNA-6231
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Assessment method [5]
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Timepoint [5]
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Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
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Eligibility
Key inclusion criteria
Key
* Understand and agree to comply with the study procedures and provide written informed consent
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Has received any investigational product (for example, study drug, biologic, device) within 30 days or 5 elimination half-lives, whichever is longer
* Pregnant or lactating women
* Men and women of childbearing potential without effective contraception during the study
* Has any lab abnormalities or clinically significant medical condition that could interfere with the interpretation of study results or limit the participant's enrollment
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/07/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/08/2022
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Sample size
Target
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Accrual to date
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Final
18
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Nucleus Network Limited - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
ModernaTX, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
There are 2 parts to this study: a single ascending dose (single dose of mRNA-6231) part and a multiple ascending dose (repeat doses of mRNA-6231) part. The main goal of this study is to evaluate the safety and tolerability of escalating doses of single and repeat subcutaneous (SC) administration of mRNA-6231. Dose levels of mRNA-6231 are planned to be investigated in a dose-escalation manner.
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Trial website
https://clinicaltrials.gov/study/NCT04916431
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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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/NCT04916431
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