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First received: February 15, 2023

Clinical Trial: Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3)

Study Status: Completed

Recruit Status: RECRUITING

Condition: Phenylketonuria

Study Type: INTERVENTIONAL


Official Title: A Phase 3, Double-blind, Placebo-controlled, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3)

Brief Summary: This is a 3-part, adaptive study consisting of a dose-escalating period (DEP) of up to 15 weeks (Part 1), followed by a 4-week, double-blind, placebo-controlled randomized withdrawal period (RWP) (Part 2), and an open-label extension (OLE) (Part 3) of up to 36 months.

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