Safety, Tolerability and Pharmacodynamics of SYNB1020
Status:
Terminated
Trial end date:
2019-07-19
Target enrollment:
Participant gender:
Summary
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.