Recent Updates
Recently added Catalysts

mRNA-6231

Phase 1

Undisclosed | RNA therapy | Other |Moderna, Inc.|Trials Updated: Aug 10, 2022

mRNA-6231 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2021

mRNA-6231 target and mechanism

Molecular targetIL-2
Target classCytokine
ModalityRNA therapy

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

mRNA-6231 clinical trials

mRNA-6231 · 1 trial · 1 indication

Phase 1 1
NCT04916431A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-6231 in Healthy AdultsHealthy Volunteers
COMPLETED18 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-6231 in Healthy Adults
Healthy VolunteersUnlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about mRNA-6231

What is mRNA-6231?

mRNA-6231 is an investigational RNA therapy developed by Moderna, Inc. It is designed to act on IL-2, a cytokine target. It has been studied in a Phase 1 clinical trial in healthy adult volunteers, and the specific medical conditions it may treat have not been disclosed.

What does mRNA-6231 target?

mRNA-6231 targets IL-2, which is a cytokine. By encoding for IL-2, the therapy is designed to interact with IL-2 biology. IL-2 is a signaling protein involved in immune cell regulation, and the drug is being developed as an RNA-based approach to this cytokine target.

Who makes mRNA-6231?

Moderna, Inc. is developing mRNA-6231. The company trades on the Nasdaq under the ticker symbol MRNA. Moderna is the sponsor of the clinical program for this RNA therapy candidate.

What phase is mRNA-6231 in?

mRNA-6231 is in Phase 1 development. It is an investigational drug and is not approved by the FDA. The Phase 1 study evaluating the candidate has been completed, and no active trials are currently listed for this program.

What clinical trials is mRNA-6231 in?

mRNA-6231 has been evaluated in one clinical trial, NCT04916431, titled a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of mRNA-6231 in healthy adults. That Phase 1 trial enrolled 18 healthy volunteers in Australia and is completed.