Skip to main content
OpenTrials
Completed

NCT Number: NCT04916431

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network Limited

Melbourne, Victoria, 3004, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mRNA-6231

Drug

Sterile frozen liquid dispersion for injection

Primary outcomes

  1. Number of Participants with Adverse Events (AEs) and Serious AEs

    Time frame: Up to Day 84

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 7, 2021
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.