Healthy VolunteersPhase 1NCT04916431
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-6231 in Healthy Adults
A Phase 1 study testing mRNA-6231 in people with Healthy Volunteers, run by ModernaTX, Inc. at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- mRNA-6231
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Jul 2021to 2 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understand and agree to comply with the study procedures and provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy Volunteers
- Being tested
- mRNA-6231
- Keywords
- mRNA-6231, Messenger RNA, Moderna
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-6231Drug
Sterile frozen liquid dispersion for injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: mRNA-6231 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs) and Serious AEs
Measured: Up to Day 84
Secondary outcomes (5)
Maximum Observed Concentration (Cmax) of mRNA (Serum) and SM-86 (Plasma)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start28 Jul 2021
- Primary completion2 Aug 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916431
- Sponsor's protocol ID
- mRNA-6231-P101
- Status last verified
- Aug 2022
- First submitted
- 1 Jun 2021
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04916431
- Acronym / sponsor ID
- mRNA-6231-P101
- Conditions
- Healthy Volunteers
- Keywords
- mRNA-6231, Messenger RNA, Moderna
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mRNA-6231 Dose Level 1 | Experimental | Drug: mRNA-6231In 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 | Experimental | Drug: mRNA-6231In 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 | Experimental | Drug: mRNA-6231In 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Understand and agree to comply with the study procedures and provide written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-6231Sterile frozen liquid dispersion for injection | Drug | mRNA-6231 Dose Level 1, mRNA-6231 Dose Level 2, mRNA-6231 Dose Level 3 |
Primary outcome
Number of Participants with Adverse Events (AEs) and Serious AEs
Time frame: Up to Day 84
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mRNA-6231 in people with Healthy Volunteers, run by ModernaTX, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AEs) and Serious AEs (time frame: Up to Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.