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

An Open-Label, Single-Dose Pharmacokinetic Study of Liquid Subcutaneous Formulation of BIO89-100 in Subjects With Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

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.

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.