Safety, Tolerability and Pharmacodynamics of SYNB1020
Stopped early · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Cirrhosis
In brief
This Phase 1b/2a, randomized, double-blind, placebo-controlled study was designed to evaluate the safety, tolerability, and pharmacodynamics of SYNB1020 in hepatic insufficiency and cirrhosis patients with hyperammonemia, with dosing of the investigational medicinal product (IMP) administered in an inpatient unit and subsequent outpatient follow-up for SYNB1020 clearance in two study parts.
Key facts
- Study ID
- NCT03447730
- Run by
- Synlogic
- People needed
- 23
- Starts
- 2018-03-19
- Expected to finish
- 2019-07-19
- Last updated by the study team
- 2021-05-13
Who can join
Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Southern California Research Center — Coronado, California, United States
- Inland Empire Liver Foundation — Rialto, California, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- Texas Liver Institute — San Antonio, Texas, United States
- McGuire VA Medical Center — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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