mRNA-3705 for Methylmalonic Acidemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Universitair Medisch Centrum Utrecht, Utrecht, NetherlandsMethylmalonic AcidemiamRNA-3705 - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This trial is studying a potential new treatment for people with a specific type of mutation that causes elevated levels of methylmalonic acid. The goal is to assess safety, how the body processes the treatment, and how well it works.

Eligible Conditions
  • Methylmalonic Acidemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: 0 (predose) to 336 hours postdose

Hour 336
Area Under the Concentration-Time Curve (AUC) of hMUT mRNA-3705
Maximum Observed Concentration (Cmax) of human Methylmalonyl-Coenzyme A Mutase (hMUT) mRNA-3705
Titer of Anti-Polyethylene Glycol (PEG) Antibodies
Hour 336
Duration of Response for Plasma Methylmalonic Acid Measurement after Single and Repeated Administrations of mRNA-3705
Week 40
Area Under the Effect Curve (AUEC) for Plasma Methylmalonic Acid Measurement after Single and Repeated Administrations of mRNA-3705
Change in 2-Methylcitric Acid (2-MC ) Levels
Change in Plasma Methylmalonic Acid Level
Maximum Observed Effect (Emax) for Plasma Methylmalonic Acid Measurement after Single and Repeated Administrations of mRNA-3705
Up to 144 weeks
The Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Study Drug-related TEAES, Serious Adverse Events (SAEs), and TEAEs Leading to Treatment Discontinuation

Trial Safety

Safety Progress

1 of 3

Similar Trials

Trial Design

1 Treatment Group

mRNA-3705
1 of 1

Experimental Treatment

33 Total Participants · 1 Treatment Group

Primary Treatment: mRNA-3705 · No Placebo Group · Phase 1 & 2

mRNA-3705
Biological
Experimental Group · 1 Intervention: mRNA-3705 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 0 (predose) to 336 hours postdose

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
72 Previous Clinical Trials
50,290,987 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 5 Total Inclusion Criteria

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Frequently Asked Questions

What is the highest capacity of participants involved in this clinical trial?

"Indeed, the information accessible on clinicaltrials.gov confirms that this research is actively seeking candidates to join. It was initially announced on August 6th 2021 and has recently been updated on June 16th 2022. The study requires 33 participants from two locations in order to continue." - Anonymous Online Contributor

Unverified Answer

What other explorations have been made regarding the efficacy of mRNA-3705?

"Currently, mRNA-3705 is the subject of 1 active clinical trial. This experiment has yet to reach Phase 3, though there are 4 sites across Toronto conducting research into this medicine's efficacy." - Anonymous Online Contributor

Unverified Answer

Is this experiment currently taking on new participants?

"Indeed, the clinicaltrials.gov confirms that this medical study is actively recruiting and has been since August 6th 2021. 33 potential participants are sought between 2 different sites, and the research was last adjusted on June 16th 2022." - Anonymous Online Contributor

Unverified Answer

Is this a groundbreaking research endeavor?

"Since 2021, mRNA-3705 has been under scientific evaluation. The initial investigation was conducted and funded by ModernaTX, Inc., with 33 participants in the trial cohort. Subsequently, the drug successfully completed Phases 1 & 2 of approval process. Currently there is one ongoing study sponsored by ModernaTX, Inc.." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.