NCT04916431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Jul 2021

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 28, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2022

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

June 1, 2021

Last Update Submit

August 9, 2022

Conditions

Healthy Volunteers

Keywords

mRNA-6231Messenger RNAModerna

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse Events (AEs) and Serious AEs

    Up to Day 84

Secondary Outcomes (5)

  • 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

Study Arms (3)

mRNA-6231 Dose Level 1

EXPERIMENTAL

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

mRNA-6231 Dose Level 2

EXPERIMENTAL

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

mRNA-6231 Dose Level 3

EXPERIMENTAL

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

Interventions

mRNA-6231DRUG

Sterile frozen liquid dispersion for injection

mRNA-6231 Dose Level 1mRNA-6231 Dose Level 2mRNA-6231 Dose Level 3

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Understand and agree to comply with the study procedures and provide written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nucleus Network Limited

Melbourne, Victoria, 3004, Australia

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 7, 2021

Study Start

July 28, 2021

Primary Completion

August 2, 2022

Study Completion

August 2, 2022

Last Updated

August 10, 2022

Record last verified: 2022-08

Locations

AU(1)