A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of mRNA 3210 in Participants with Phenylketonuria

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506963-32-00

Acronym

mRNA 3210-P101

Enrollment

Registered

2024-07-16

Start date

Unknown

Completion date

2024-09-12

Last updated

2024-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Participants with Phenylketonuria

Brief summary

Number of participants with TEAEs.

Detailed description

• Changes from baseline in blood Phe levels. • Characterization of PD parameters, including Emax, AUEC, and duration of response., • Characterization of blood PK parameters of mRNA and SM 86, including, but not limited to, Cmax, Tmax, AUC, t½, CL, and Vz., • Presence and titers of anti-PEG antibodies.

Interventions

DRUGHYDROXYZINE

DRUGPARACETAMOL

DRUGIBUPROFEN

DRUGCETIRIZINE

DRUGFEXOFENADINE

DRUGmRNA-3210

DRUGFAMOTIDINE

DRUGDIPHENHYDRAMINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of participants with TEAEs.	—

Secondary

Measure	Time frame
• Changes from baseline in blood Phe levels. • Characterization of PD parameters, including Emax, AUEC, and duration of response., • Characterization of blood PK parameters of mRNA and SM 86, including, but not limited to, Cmax, Tmax, AUC, t½, CL, and Vz., • Presence and titers of anti-PEG antibodies.	—

Countries

France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026