Efficacy and Safety of SYNB1618 and SYNB1934 in Adult Patients With Phenylketonuria
(SynPheny-1 Trial)
Recruiting in Palo Alto (17 mi)
+10 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Synlogic
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This Phase 2 study in patients with phenylketonuria (PKU) will be an open-label, dual-arm study of either a SYNB1618 or SYNB1934 dose-ramp regimen. All evaluations and assessments throughout this study may be conducted either at the clinical site or by a home healthcare professional at an alternative location (e.g., patient's home, hotel).
Eligibility Criteria
Inclusion Criteria
Age ≥ 18 years.
Able and willing to voluntarily complete the informed consent process.
Diagnosis of classic PKU based on medical history as assessed by the investigator (e.g., Phe concentration of >1200 µmol/L at any time, low dietary Phe tolerance, or genetic diagnosis).
+7 more
Participant Groups
2Treatment groups
Experimental Treatment
Group I: SYNB1934Experimental Treatment1 Intervention
Dose ramp of SYNB1934
Group II: SYNB1618Experimental Treatment1 Intervention
Dose ramp of SYNB1618
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Hospital ColoradoAurora, CO
University of Pittsburgh Medical CenterPittsburgh, PA
Vanderbilt University Medical CenterNashville, TN
University of Texas Health Science Center at HoustonHouston, TX
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
SynlogicLead Sponsor