Clinical Trial 48188

Aurora, CO 80045


Summary:

<b>Phenylketonuria (PKU) - Multiple Locations in the US</b>

WHAT’S NEW IN PKU?

    Synlogic is conducting a phase 2 open-label clinical research study to evaluate the safety of potential new treatment options for PKU. We’re seeking adult patients with classic PKU to participate in the study.

    STUDY DURATION:

    • Up to 52-day screening
    • 15-day treatment period
    • 31-day follow-up period

    INVESTIGATIONAL DRUGS

    • SYNB1618 and SYNB1934, both modified probiotics
    • Designed to break down phenylalanine in the diet
    • Given orally as a liquid
    • This is the third clinical study of SYNB1618 and second clinical study of SYNB1934

    KEY ELIGIBILITY CRITERIA

    • Age 18 and up
    • Have been diagnosed with classic PKU
    • Not currently taking pegylated recombinant phenylalanine ammonia lyase (PALYNZIQ®) (within 1 month of screening)

    ALL ELIGIBLE PARTICIPANTS WILL RECEIVE AT NO COST

    • Close care and monitoring throughout the study
    • Investigational drugs
    • All study-related visits
    • Compensation for participation, including travel and study-related activities


    Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.