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Purpose

The purpose of this study is to evaluate the safety, tolerability, and efficacy of MZE782 in adults with Phenylketonuria (PKU).

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Exclusion Criteria

  • Is pregnant, breastfeeding, or planning to become pregnant or conceive a child during the study or within 90 days after the last dose - Medical conditions or abnormal test results that could make participation unsafe or make it difficult to complete study procedures or interpret study results - Has recently received another investigational drug - Is unable to swallow tablets or tolerate oral medication Other inclusion/exclusion criteria defined in protocol apply.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MZE782 Low Dose (Cohort 1A)
  • Drug: MZE782
    Tablet, Low Dose
Placebo Comparator
Placebo (Cohort 1A)
  • Other: Placebo
    Tablet
Experimental
MZE782 High Dose (Cohort 1B)
  • Drug: MZE782
    Tablet, High Dose
Placebo Comparator
Placebo (Cohort 1B)
  • Other: Placebo
    Tablet
Experimental
MZE782 High Dose (Cohort 2)
  • Drug: MZE782
    Tablet, High Dose
Placebo Comparator
Placebo (Cohort 2)
  • Other: Placebo
    Tablet

Recruiting Locations

Clinic for Special Children
Gordonville, Pennsylvania 17529

More Details

Status
Recruiting
Sponsor
Maze Therapeutics

Study Contact

Maze Therapeutics
650-850-5075
medicalinfo@mazetx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.