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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: mRNA-6231

• Registration Number: NCT04916431
• Lead Sponsor: ModernaTX, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-01
• Study First Posted: 2021-06-07
• Study Start: 2021-07-28
• Status Verified: 2022-08
• Primary Completion: 2022-08-02
• Study Completion: 2022-08-02
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
mRNA-6231 Dose Level 1	mRNA-6231	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.
mRNA-6231 Dose Level 2	mRNA-6231	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.
mRNA-6231 Dose Level 3	mRNA-6231	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs) and Serious AEs	Up to Day 84

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Nucleus Network Limited; 🇦🇺 Melbourne, Victoria, Australia