Recruiting
Phase 1
Phase 2

mRNA-3927

Sponsor:

Moderna

Code:

NCT05130437

Conditions

Propionic Acidemia

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Interventions

mRNA-3927

Study Details

Brief summary:

The main purpose of this study is to evaluate the long-term safety of mRNA-3927 administered to participants with propionic acidemia (PA) who have previously participated in Study mRNA-3927-P101 (NCT04159103).

Conditions

Propionic Acidemia

Study ID

NCT05130437

Start date

Nov 9, 2021

Status verified date

Mar, 2026

Completion date

Dec 4, 2031

Anticipated

Primary completion date

Dec 4, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participated in Study mRNA-3927-P101.
  • Completed the EOT/ET visit in Study mRNA-3927-P101 and enroll in this study such that the first dose in this study is planned to be within 14±3 days of the last dose of mRNA-3927 in the mRNA-3927-P101 study.

Exclusion Criteria:

  • Not expected to receive clinical benefit from continued mRNA-3927 administration, in the opinion of the Investigator.
  • Any clinical or laboratory abnormality or medical condition that, at the discretion of the Investigator, may put the individual at increased risk by participating in this study.
  • History of liver and/or kidney transplant.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: mRNA-3927

Participants will receive the applicable dose identified during Study mRNA-3927-P101 (NCT04159103) on Day 1. The dose can be adjusted based on Sponsor recommendation.

Interventions

mRNA-3927

mRNA-3927 dispersion for IV infusion

Primary outcome measure

  • Number of Participants with Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation [ Time Frame: Baseline through End of Study Visit (up to 8 years) ]

Central Contacts and Locations

Central contacts

Moderna WeCare Team

1-866-663-3762WeCareClinicalTrials@modernatx.com

Locations

University of Stanford Medical Center

Recruiting

Palo Alto, California, United States, 94304-1503

University of Michigan Hospitals

Recruiting

Ann Arbor, Michigan, United States, 48109

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Duke University Medical System (Duke Health)

Recruiting

Durham, North Carolina, United States, 27710

The Children's Hospital of Philadelphia (CHOP)

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Hospital For Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

More Information

Sponsor

ModernaTX, Inc.

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

  • mRNA-3927
  • Propionic Aciduria
  • Metabolism, Inborn Errors
  • Genetic Diseases
  • Inborn Amino Acid Metabolism, Inborn Errors
  • Acidosis
  • Acid-Base Imbalance
  • Metabolic Diseases
  • Organic Acidemias
  • Moderna
  • mRNA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ModernaTX, Inc. on 2026-03-23.