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.

Study Overview

• Status: Completed
• Conditions: NASH - Nonalcoholic Steatohepatitis
• Intervention / Treatment: Drug: BIO89-100

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • 89bio Clinical Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIO89-100 30 mg, Open Lable, Single Dose	Drug: BIO89-100; Subcutaneous Injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK Profile of liquid formulation of BIO89-100	Determine maximum observed serum drug concentration (Cmax)	22 days
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: 89bio, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Actual): December 21, 2021
• Study Completion (Actual): December 21, 2021

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: BIO89-100-111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No