A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Tolerability, and Efficacy of MZE782 in Adults With Phenylketonuria (PKU)
Maze Therapeutics
Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of MZE782 in adults with Phenylketonuria (PKU).
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Males and females 18 to 75 years old * Clinical diagnosis of PKU * Willing and able to keep diet and protein intake consistent during the study * For some study groups, is willing and able to stop certain PKU medications before starting study treatment * For some study groups, may need to meet additional blood phenylalanine level or background-treatment requirements * Meets minimum blood phenylalanine level requirements for study group Key Exclusion Criteria: * Is pregnant, breastfeeding, or planning to become pregnant or conceive a child during the study or within…
Interventions
- DrugMZE782
Tablet, Low Dose
- OtherPlacebo
Tablet
- DrugMZE782
Tablet, High Dose
Location
- Clinic for Special ChildrenGordonville, Pennsylvania