A clinical study to evaluate mRNA-3705 in Patients with MMA

You likely can't join if

• 1. Participant has a diagnosis of isolated MMA cb1A, cb1B, or cb1D enzymatic subtypes or methylmalonyl-CoA epimerase deficiency or combined MMA with homocystinuria. 2. Participant has any individual laboratory abnormalities achieving exclusionary thresholds defined in Table 16. 3. Participant has previously received gene therapy for the treatment of MMA. 4. Participant has an eGFR <30 mL/min/1.73 m2, as estimated by the Schwartz formula for participants <18 years of age (Schwartz et al 2009), or by the Chronic Kidney Disease Epidemiology Collaboration creatinine-based formula for participants ≥18 years of age (Inker et al 2021), or receives long-term dialysis. 5. Participant has a corrected QT interval >480 ms using Bazett’s correction. 6. For participants of reproductive potential, the participant has a positive pregnancy test at the Screening Visit. 7. Participant is pregnant or breastfeeding. 8. Participant has a history of organ transplantation or planned organ transplantation during the period of study participation. 9. Participant has a history of hypersensitivity to any components of the study drug. 10. Participant has a history of hypersensitivity or contraindication to acetaminophen/paracetamol and/or ibuprofen or H1/H2 receptor blockers. 11. Participation in another clinical study of another investigational agent within 30 days before study entry or within 5 elimination half-lives of the investigational agent, whichever is longer. 12. Participant has undergone a major surgical procedure within 30 days before the Screening Visit (excludes central line, port, or feeding tube placement). 13. Participant has new uses or adjusted dosage of antibiotic therapy used to reduce propionate production within 2 weeks before first dose of study drug. 14. Any participant with a new or adjusted dosage of antibiotics may enter the Treatment Period after 2 weeks of stable antibiotic regimen. 14. This criterion has been removed and integrated into Exclusion Criterion 13 in Protocol Amendment 9. 15. Participant has an active, unstable, or clinically significant medical condition not related to MMA or history of noncompliance that, in the Investigator’s opinion, could potentiate the risk while participating in this study, interfere with the interpretation of study results, or limit the participant’s participation in the study. This may include, but is not limited to, history of relevant food or drug allergies; history of cardiovascular, central nervous, gastrointestinal, or infectious disease; history of clinically significant pathology; and/or history of cancer. 16. Participant has received COVID-19 vaccination (generally 2 doses or a booster) within 28 days prior to first study drug administration. 17.This criterion has been removed in Protocol Amendment 10. 18. Participant has a history of anaphylaxis/anaphylactoid reaction or severe hypersensitivity with infusions. 19. This criterion has been removed in Protocol Amendment 9. 20. (Part 2 only) Participant has the mut- disease phenotype, as assessed by genotyping, clinical phenotype/presentation, or Vitamin B12-responsive MMA.