A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-6231 in Healthy Adults

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: mRNA-6231


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mRNA-6231 Dose Level 1<br>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<br>* Sterile frozen liquid dispersion for injection<br>|
| Experimental: mRNA-6231 Dose Level 2<br>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<br>* Sterile frozen liquid dispersion for injection<br>|
| Experimental: mRNA-6231 Dose Level 3<br>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<br>* Sterile frozen liquid dispersion for injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events (AEs) and Serious AEs |  | Up to Day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Maximum Observed Effect (Emax) of mRNA-6231 |  | 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 |  | Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mRNA-6231, Messenger RNA, Moderna