Phenylketonuria (PKU) - Multiple Locations in the US (Clinical Trial 41224)

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Study summary

WHAT’S NEW IN PKU?

Synlogic is conducting a Phase 1 clinical research study to evaluate the safety of a potential new treatment option for PKU. We’re seeking adult patients with classic PKU to participate in the study.

STUDY OVERVIEW

Phenylketonuria (PKU) is a rare genetic disorder affecting about 16,500 people in the U.S. PKU is caused by a defect in the gene that helps create the enzyme responsible for breaking down an amino acid called phenylalanine. Phenylalanine builds up in the body, causing health problems like:

Trouble focusing or concentrating
Neurological problems, including seizures
Behavioral, emotional, or social problems
Irreversible brain damage

With strict diet management you can manage your symptoms and prevent health problems. However, if you’re looking for more options to help you better manage your PKU, you may be interested in this study investigating a new oral treatment option.

STUDY DURATION: 19 weeks, including:

60-day screening
10-day inpatient treatment period
8-week follow-up period

INVESTIGATIONAL DRUG

SYNB1618, a modified probiotic
Designed to break down phenylalanine in the diet
Given orally as a liquid

KEY ELIGIBILITY CRITERIA

Between ages 18 and 64 (inclusive)
Have been diagnosed with classic PKU
Not currently taking sapropterin (KUVAN®) (within the past week) or pegylated recombinant phenylalanine ammonia lyase (PALYNZIQ^TM) (within the past 6 months)

ALL ELIGIBLE PARTICIPANTS WILL RECEIVE AT NO COST

Close care and monitoring throughout the study
Investigational drug or placebo
All study-related visits
Compensation for participation, including travel and study-related activities

See if you may be eligible.

Study is available at

This study is being conducted NATIONWIDE! To find clinics conducting this study near you please use search feature below.

Study Locations

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