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NCT04916431 Clinical Trial

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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04916431
Other study ID # mRNA-6231-P101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 28, 2021
Est. completion date August 2, 2022

Study information
Verified date August 2022
Source ModernaTX, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date August 2, 2022
Est. primary completion date August 2, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• mRNA-6231
Sterile frozen liquid dispersion for injection

Locations
Country Name City State
Australia Nucleus Network Limited Melbourne Victoria

Sponsors (1)
Lead Sponsor Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events (AEs) and Serious AEs Up to Day 84
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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