SYNB1934 for Phenylketonuria
(SYNPHENY-3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests SYNB1934v1, a new treatment for people with high blood phenylalanine (Phe) levels. The goal is to find the best dose that reduces Phe levels by at least 20% without causing side effects.
Will I have to stop taking my current medications?
The trial requires that you continue your current diet, sapropterin, sepiapterin, and large neutral amino acids without changes during the study. However, you cannot take Palynziq® (pegvaliase-pqpz) within 1 month of screening or any systemic antibiotics within 28 days prior to the first dose.
Are You a Good Fit for This Trial?
Adults with Phenylketonuria (PKU) who haven't been able to control their blood Phe levels using current treatments can join. They should be on a stable diet and treatment for at least 1 month, agree to not change their diet or PKU management during the trial, and use contraception if applicable. Pregnant women, those on recent investigational drugs, antibiotics, or specific PKU therapies like Palynziq®, are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose-escalating, open-label period (DEP)
Participants receive escalating doses of SYNB1934v1 to determine an individually titrated dose (iTD)
Randomized withdrawal period (RWP)
Participants are randomized to receive SYNB1934v1 or placebo to assess efficacy and safety
Open-label extension (OLE)
Participants may continue receiving SYNB1934v1 with dose adjustments based on tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- SYNB1934
Find a Clinic Near You
Who Is Running the Clinical Trial?
Synlogic
Lead Sponsor