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mRNA-6231

Phase 1

Healthy Volunteers | Small molecule | Other |Moderna, Inc.|Last Updated: Aug 10, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04916431A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-6231 in Healthy AdultsPHASE1 COMPLETED 18 — — Jul 28, 2021Aug 2, 2022Aug 10, 20221 Australia
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Study Endpoints
Primary Endpoints
Number of Participants with Adverse Events (AEs) and Serious AEs
Up to Day 84
Secondary Endpoints
Maximum Observed Concentration (Cmax) of mRNA (Serum) and SM-86 (Plasma)
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)
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
Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
mRNA-6231 Dose Level 1EXPERIMENTALIn 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.
mRNA-6231 Dose Level 2EXPERIMENTALIn 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.
mRNA-6231 Dose Level 3EXPERIMENTALIn 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.
Interventions
NameTypeDescription
mRNA-6231DRUGSterile frozen liquid dispersion for injection
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Understand and agree to comply with the study procedures and provide written informed consent 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 * ...

Countries:Australia
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