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

NASH - Nonalcoholic Steatohepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05022693
• Other study ID #: BIO89-100-111
• Status: Completed
• Phase: Phase 1
• Start date: August 16, 2021
• Est. completion date: December 21, 2021

Study information

• Verified date: February 2022
• Source: 89bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 21, 2021
• Est. primary completion date: December 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• BIO89-100
Subcutaneous Injections

Locations

Country	Name	City	State
United States	89bio Clinical Study Site	Chandler	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
89bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK Profile of liquid formulation of BIO89-100	Determine maximum observed serum drug concentration (Cmax)	22 days
Primary	PK Profile of liquid formulation of BIO89-100	Area under the serum drug concentration-by-time curve from time 0 to the time of the last quantifiable drug concentration (AUC0-t)	22 days
Secondary	Evaluate the safety and tolerability of the BIO89-100 liquid formulation	Frequency and severity of adverse events (AEs) and serious adverse events (SAEs); Number of subjects who discontinued due to AEs and due to related AEs	22 days