The main goal of this study is to assess the safety, and tolerability of multiple doses of mRNA-3210 in participants with phenylketonuria (PKU).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
IV infusion
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Day 1 up to 52 weeks after EOT (up to 91 weeks)
Change from Baseline in Blood Phenylalanine Levels
Time frame: Day 1 up to 52 weeks after EOT (up to 91 weeks)
Maximum Observed Effect (Emax)
Time frame: Day 1 up to 52 weeks after EOT (up to 91 weeks)
Area Under the Effect Versus Time Curve (AUEC)
Time frame: Day 1 up to 52 weeks after EOT (up to 91 weeks)
Maximum Observed Concentration (Cmax)
Time frame: Day 1 through Day 15 for Dose 1 and Dose 12
Area Under the Plasma Concentration-Time Curve (AUC)
Time frame: Day 1 through Day 15 for Dose 1 and Dose 12
Number of Participants with Anti-Polyethylene Glycol Antibodies
Time frame: Day 1 up to 52 weeks after EOT (up to 91 weeks)
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