PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, single-dose study to evaluate the PK profile of the liquid SC formulation of BIO89-100 in approximately 8 male and female subjects with NASH with compensated cirrhosis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 89bio, Inc.

Criteria

Key Inclusion Criteria:

• Age 21 to 65

• Diagnosis of NASH with compensated cirrhosis by a hepatologist based on Liver Forum criteria.

• Model for End-Stage Liver Disease (MELD) score < 12.

• Child-Turcotte-Pugh (CTP) score < 7 (Class A).

• Fibrosis stage F4 by FibroScan.

Key Exclusion Criteria:

• History of hepatic cirrhosis decompensation, OR overt hepatic encephalopathy OR signs of hepatic cirrhosis decompensation.

• Prior transjugular intrahepatic portosystemic (TIPS) shunt procedure.

• known condition other than cirrhosis that may possibly interfere with drug absorption, distribution, metabolism, or excretion.

• Significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening.