NCT06147856 is a Phase 1, PHASE2 clinical trial of mRNA-3210 in Phenylketonuria, sponsored by ModernaTX, Inc..

Who is sponsoring NCT06147856?

NCT06147856 is sponsored by ModernaTX, Inc..

What drugs are being tested in NCT06147856?

Interventions in NCT06147856: mRNA-3210.

What condition does NCT06147856 study?

NCT06147856 studies Phenylketonuria.

Is NCT06147856 still recruiting?

NCT06147856 is currently withdrawn. Last updated 22 October 2024.

Last reviewed 2024-10-22 · How we verify

NCT06147856

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Dose-finding Study to Evaluate mRNA-3210 in Participants With Phenylketonuria

Withdrawn Phase 1, PHASE2 Last updated 22 October 2024

What this trial tests

Phase 1, PHASE2 trial testing mRNA-3210 in Phenylketonuria. Withdrawn.

Timeline

29 March 2024

Primary endpoint
10 August 2026

5 August 2027

Quick facts

Lead sponsor	ModernaTX, Inc.
Phase	Phase 1, PHASE2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	29 March 2024
Primary completion	10 August 2026
Estimated completion	5 August 2027

Drugs / interventions tested

mRNA-3210 — full drug profile →

Conditions studied

Phenylketonuria — all drugs for Phenylketonuria →

Sponsor

ModernaTX, Inc. — full company profile →

Who can join

Adults 18 to 70, any sex, with Phenylketonuria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main goal of this study is to assess the safety, and tolerability of multiple doses of mRNA-3210 in participants with phenylketonuria (PKU).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

RNA-based therapies in liver metabolic diseases.
Fontanellas A, Berraondo P, Urigo F, Jericó D, et al · · 2025 · cited 9× · PMID 39988358 · DOI 10.1136/gutjnl-2023-331742
Current state of the treatment landscape of phenylketonuria.
Nulmans I, Lequeue S, Desmet L, Neuckermans J, et al · · 2025 · cited 8× · PMID 40474275 · DOI 10.1186/s13023-025-03840-y
Engineering Lipid Nanoparticles for mRNA Immunotherapy.
Zwolsman R, Darwish YB, Kluza E, van der Meel R. · · 2025 · cited 8× · PMID 40195623 · DOI 10.1002/wnan.70007
Design Strategies for Novel Lipid Nanoparticle for mRNA Vaccine and Therapeutics: Current Understandings and Future Perspectives.
Li X, Li J, Wei J, Du W, et al · · 2025 · cited 7× · PMID 41059491 · DOI 10.1002/mco2.70414
Delivering the Message: Translating mRNA Therapy for Liver Inherited Metabolic Diseases.
Gurung S, Perocheau D, Ghosh R, Hart SL, et al · · 2025 · cited 5× · PMID 40826824 · DOI 10.1002/jimd.70078
Bridging gene therapy and next-generation vaccine technologies.
Bloom K, Ely A, Maepa MB, Arbuthnot P. · · 2025 · cited 4× · PMID 39558149 · DOI 10.1038/s41434-024-00502-9
Nonviral targeted mRNA delivery: principles, progresses, and challenges.
He X, Li G, Huang L, Shi H, et al · · 2025 · cited 3× · PMID 39760110 · DOI 10.1002/mco2.70035
RNA-Based Therapies for Inherited Metabolic Disorders.
Vootukuri RS, Gurung S, Ghosh R, Mills PB, et al · · 2026 · cited 1× · PMID 41621836 · DOI 10.1002/jimd.70150

Verify or expand the search:

Other recruiting trials for Phenylketonuria

Currently open trials in the same condition.

NCT06971731 — A Study to Evaluate the Safety and Efficacy of JNT-517 in Participants With Phenylketonuria (PKU) · Phase 3 · recruiting
NCT07526909 — Effect of Different Meal Types Given Before Exercise on Plasma Amino Acid Levels and Metabolic Control Parameters in Cla · NA · recruiting
NCT06941532 — GMP Powdered Substitutes in PKU and TYR · NA · recruiting
NCT06901323 — Effect of L-carnitine Supplementation on Phenylalanine and Brain-derived Neurotrophic Factor Levels in Infants and Child · Phase 4 · active not recruiting
NCT06302348 — A Study of Sepiapterin in Participants With Phenylketonuria (PKU) · Phase 3 · recruiting

Other ModernaTX, Inc. trials

Trials by the same sponsor.

NCT07496450 — A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults · Phase 3 · recruiting
NCT07478952 — A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189 in Healthy Adults 18 to 30 Years of Age · Phase 1 · recruiting
NCT07266558 — A Study to Evaluate the Efficacy and Safety of mRNA-1283 and mRNA-1273 in Participants 50 to 64 Years of Age Without Hig · Phase 4 · recruiting
NCT07116616 — A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma · Phase 1, PHASE2 · recruiting
NCT07117487 — A Study of mRNA-1345 Following a Primary Dose of a Licensed Protein Subunit Respiratory Syncytial Virus (RSV) Vaccine in · Phase 3 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06147856 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ModernaTX, Inc.
Last refreshed: 22 October 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06147856.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing