Safety and Tolerability of Yaq-001 in Patients With Cirrhosis

First-in-human clinical investigation with Yaq-001. This is a multicentre, randomized, double blinded, placebo controlled trial to intended to evaluate safety and tolerability of oral administration of Yaq-001 therapy in two dosing cohorts.

56 cirrhotic patients with diuretic-responsive ascites will be enrolled. Patients will be randomized to two dosing cohorts.

Cohort 1 (1:1 randomization)

* Standard medical treatment + Yaq-001 (4 g/ day) - n= 14. * Standard medical treatment + placebo-control (placebo for 4 g of Yaq-001/ day) - n= 14.

Cohort 2 (1:1 randomization)

* Standard medical treatment + Yaq-001 (8 g/ day) - n= 14. * Standard medical treatment + placebo-control (placebo for 8 g of Yaq-001/ day) - n= 14.

Study patients will be dosed daily with Yaq-001 (or an equivalent quantity of placebo) for 12 weeks. Assessments of DSMB will take place after 4 and 12 weeks. Investigational centres specialized in the management of patients with liver cirrhosis will participate in the study.

For each patient, the study duration will be up to 17 weeks, including the screening (up to 4 weeks), treatment (12 weeks) and 7-day follow up period.

The total study duration is estimated to be approximately 6 months from screening of first patient until study completion of the last patient.

This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 634579.