Last updated on May 2019

Safety Tolerability and Pharmacodynamics of SYNB1020


Brief description of study

This is a phase 1b/2a, randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability and pharmacodynamics of SYNB1020 in hepatic insufficiency and cirrhosis patients.

Detailed Study Description

This study consists of two parts:

Part 1 (Completed):

A sentinel open-label cohort of subjects with cirrhosis and Model for End-Stage Liver Disease (MELD) score <12 will be admitted to an inpatient facility for a run in diet, baseline assessments, IP administration, safety monitoring, and collection of blood, urine, and fecal samples for evaluation of safety, tolerability, and pharmacokinetics and PD evaluations. Once the safety and tolerability have been established in Part 1, enrollment will be opened to subjects in Part 2.

Part 2:

Part 2 of the trial will comprise a randomized, double-blinded, placebo-controlled study in subjects with cirrhosis and hyperammonemia. Subjects may be pre screened for eligibility based on medical history and a single fasting spot venous ammonia measurement. Eligible subjects with elevated fasting spot venous ammonia will then undergo full screening within 7 days of pre screening. Eligible subjects will be admitted to an inpatient facility for a run-in diet and 24-hour ammonia profile, and those with an elevated 24-hour ammonia AUC will proceed with randomization, IP administration, safety monitoring, and collection of blood, urine, and fecal samples for pharmacokinetic and pharmacodynamic (PD) evaluations.

Clinical Study Identifier: NCT03447730

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