A Phase 1 interventional study of mRNA-6231 in Healthy Volunteers, sponsored by ModernaTX, Inc.. Completed at 1 site in Australia. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-10.
Sponsored by ModernaTX, Inc. · Phase 1, Interventional, and Treatment
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.
ModernaTX, Inc. is the lead sponsor of 112 studies on the registry; 14 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 32 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
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.
Drug: mRNA-6231
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.
Drug: mRNA-6231
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.
Drug: mRNA-6231
Sterile frozen liquid dispersion for injection
Number of Participants with Adverse Events (AEs) and Serious AEs
Time frame: Up to Day 84
Maximum Observed Concentration (Cmax) of mRNA (Serum) and SM-86 (Plasma)
Time frame: Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
Area Under the Concentration-Time Curve (AUC) of mRNA (Serum) and SM-86 (Plasma)
Time frame: Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
Time to Maximum to Observed Effect (TEmax) of mRNA-6231
Time frame: Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
Maximum Observed Effect (Emax) of mRNA-6231
Time frame: Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
Area Under the Effect Versus Time Curve (AUEClast) of mRNA-6231
Time frame: Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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ModernaTX, Inc.