Safety, Tolerability and Pharmacodynamics of SYNB1020

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.

Timeline

Start

2018-03-19

Primary completion

2019-07-19

Completion

2019-07-19

Outcome

Outcome not reported

Stopped: “Interim futility analyses identified a lack of SYNB1020 efficacy.”

Drugs

Indications