Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3)

PHASE3TerminatedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

July 5, 2023

Primary Completion Date

March 15, 2024

Study Completion Date

March 15, 2024

Conditions
Phenylketonuria
Interventions
DRUG

SYNB1934v1

SYNB1934v1 consisted of powder for oral suspension packaged in sachets. During dose preparation, the powder was resuspended in water or apple juice prior to administration.

DRUG

Placebo

Placebo was manufactured using an inactive powder that was color matched to the SYNB1934v1 drug product. In order to maintain study blinding during the RWP, placebo was packaged, labeled, stored, and administered in an identical manner to SYNB1934v1.

Trial Locations (21)

15224

University of Pittsburgh Medical Center - Children's Hospital of Pittsburgh, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

29425

Medical University of South Carolina, Pediatrics, Charleston

32610

University of Florida - Gainesville, Gainesville

35340

Dokuz Eylül Üniversitesi Araştırma ve Uygulama Hastanesi, Balçova

37232

Division of Medical Genetics-Pediatrics, Vanderbilt University Medical Center, Nashville

75390

UT Southwestern Medical Center, Dallas

77030

McGovern Medical School/Memorial Hermann Hospital, Houston

80045

University of Colorado Children's Hospital, Aurora

90230

Science 37, Culver City

92868

Children's Hospital Orange County, Orange

94304

Stanford University, Department of Pediatrics, Palo Alto

97239

Oregon Health and Science University Department of Molecular and Medical Genetics, Portland

60611-2991

Ann & Robert H. Lurie Children's Hospital of Chicago, Pediatrics, Chicago

02114

Massachusetts General Hospital, Department of Pediatrics, Boston

T2E 7Z4

MAGIC Clinic, Calgary

L8N 3Z5

Hamilton Health Sciences Corporation, Hamilton

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

M5T 3L9

University Health Network, Toronto

0159

Medical Genetics and Laboratory Diagnostics Center, Tbilisi

06560

Gazi Üniversitesi Hastanesi, Yenimahalle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Synlogic

INDUSTRY

NCT05764239 - Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3) | Biotech Hunter | Biotech Hunter