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NCT04899310 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of mRNA-3705 in Participants With Isolated Methylmalonic Acidemia
A Phase 1 study of Methylmalonic Acidemia, sponsored by ModernaTX.
- Active
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
- 11
- Study locations
NCT04899310 is a Phase 1 study of Methylmalonic Acidemia that is active but no longer recruiting, run by ModernaTX. The registered enrollment target is 74 participants, below the 415-participant average among 6 other Methylmalonic Acidemia trials with a reported enrollment target (82% lower). The trial reports 11 study locations across 5 states.
The verdict
NCT04899310, a Phase 1 study of Methylmalonic Acidemia, is active but no longer recruiting, sponsored by ModernaTX.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
- 11
- Study locations
Study Summary
This is a study of mRNA-3705 in participants with isolated elevated methylmalonic acid (MMA) due to methylmalonyl-coenzyme A (CoA) mutase (MUT) deficiency. The main goal of the study is to assess safety, efficacy, pharmacokinetics, and pharmacodynamics of intravenously (IV)-infused mRNA-3705.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL mRNA-3705
Study Locations (11)
Other
- Hôpital Necker - Enfants Malades - Paris
- Erasmus MC - Rotterdam
- Universitair Medisch Centrum Utrecht - Utrecht
- Hospital Universitario Cruces - Barakaldo
- Hospital Universitario 12 de Octubre - Madrid
- Royal Manchester Children's Hospital - Manchester
California
- UCLA Medical Center - Los Angeles
- Lucile Packard Children's Hospital at Stanford - Palo Alto
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
Alberta
- Stollery Children's Hospital University of Alberta - Edmonton
Ontario
- Hospital For Sick Children - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2021-08-06 |
| Est. Completion | 2028-07-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04899310
The ClinicalTrials.gov registry entry for NCT04899310 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 415-participant average among 6 other Methylmalonic Acidemia trials with a reported enrollment target (82% lower). The listed sponsor is ModernaTX, which has 90 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Methylmalonic Acidemia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04899310 reports 11 study locations spanning 5 distinct geographic areas - top geographies include Other, California, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04899310 about?
NCT04899310 is a clinical study titled "A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of mRNA-3705 in Participants With Isolated Methylmalonic Acidemia". This is a study of mRNA-3705 in participants with isolated elevated methylmalonic acid (MMA) due to methylmalonyl-coenzyme A (CoA) mutase (MUT) deficiency. The main goal of the study is to assess safety, efficacy, pharmacokinetics, and pharmacodynamics of intravenously (IV)-infused mRNA-3705.
What is the current status of trial NCT04899310?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2021-08-06. Estimated completion is 2028-07-01.
What conditions does trial NCT04899310 study?
This clinical trial studies the following conditions: Methylmalonic Acidemia.
What interventions are being tested in trial NCT04899310?
The interventions under investigation include: Placebo (BIOLOGICAL), mRNA-3705 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04899310?
This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04899310 being conducted?
This trial has 11 study locations across California, Pennsylvania, Alberta, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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