A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of mRNA-3705 in Participants With Isolated Methylmalonic Acidemia
← catalyst calendarSponsored by ModernaTX, Inc. (industry) · MRNA — their whole pipeline →.
Phase
Phase 1/2
Status
Terminated
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
18actual
Sites
11
Countries
Canada, France, Netherlands +3
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
As part of ongoing efforts to refine the MMA program strategy, we are reevaluating clinical study plans for mRNA-3705, in order to further optimize the development program. As part of this process, Moderna will be closing the mRNA-3705-P101 study.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-08-06 | actual | When the study began enrolling |
| Primary completion | 2026-04-01 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-04-01 | actual | The whole study's end, after follow-up |
| First posted | 2021-05-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Methylmalonic Acidemia
Interventions
- Biological: mRNA-3705 — also filed as modified mRNA encoding human, methylmalonyl-coenzyme A mutase
- Biological: Placebo
Primary outcomes
what the primary-completion date above is the date OFParts 1 and 3: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Study Drug-related TEAEs, Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and TEAEs Leading to Treatment Discontinuation
measured Up to 134 weeks
Part 2: Percentage Change in Plasma MMA Levels at Month 3
measured Baseline, Month 3
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