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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/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
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
Secondary ID [1] 0 0
mRNA-6231-P101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events (AEs) and Serious AEs
Timepoint [1] 0 0
Up to Day 84
Secondary outcome [1] 0 0
Maximum Observed Concentration (Cmax) of mRNA (Serum) and SM-86 (Plasma)
Timepoint [1] 0 0
Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
Secondary outcome [2] 0 0
Area Under the Concentration-Time Curve (AUC) of mRNA (Serum) and SM-86 (Plasma)
Timepoint [2] 0 0
Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
Secondary outcome [3] 0 0
Time to Maximum to Observed Effect (TEmax) of mRNA-6231
Timepoint [3] 0 0
Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
Secondary outcome [4] 0 0
Maximum Observed Effect (Emax) of mRNA-6231
Timepoint [4] 0 0
Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
Secondary outcome [5] 0 0
Area Under the Effect Versus Time Curve (AUEClast) of mRNA-6231
Timepoint [5] 0 0
Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29

Eligibility
Key inclusion criteria
Key

- Understand and agree to comply with the study procedures and provide written informed
consent

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/08/2022
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Limited - 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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04916431
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04916431