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

89bio

Status and phase: Completed; Phase 1

Conditions: NASH - Nonalcoholic Steatohepatitis

Treatments: Drug: BIO89-100

Study type: Interventional

Funder types: Industry

Identifiers

NCT05022693

BIO89-100-111

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

BIO89-100 30 mg, Open Lable, Single Dose

Experimental group

Treatment:

Drug: BIO89-100