MedTrace Logo

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

NCT05764239 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-06-20

Study results available
· View outcomes & findings →

Summary

SYNB1934-CP-003 was designed as a 3-part, adaptive study consisting of a dose-escalating, open-label period (DEP; Part 1) of up to 15 weeks, followed by a 4-week, double-blind, placebo-controlled, randomized withdrawal period (RWP; Part 2), and an open-label extension (OLE; Part 3) of up to 36 months

Conditions

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.

Sponsors & Collaborators

  • Synlogic

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-05
Primary Completion
2024-03-15
Completion
2024-03-15
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Georgia
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05764239 on ClinicalTrials.gov