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

NCT05022693 | Completed Phase 1 FDA Drug

• 1 other identifier: BIO89-100-111
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NASH - Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Evaluate the safety and tolerability of the BIO89-100 liquid formulation

  22 days

Study Arms (1)

BIO89-100 30 mg, Open Lable, Single Dose

EXPERIMENTAL

Drug: BIO89-100

Interventions

BIO89-100 DRUG

Subcutaneous Injections

BIO89-100 30 mg, Open Lable, Single Dose

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 89bio, Inc.: lead

Study Sites (1)

89bio Clinical Study Site

Chandler, Arizona, 85224, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, single dose, PK study

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 26, 2021
• Study Start: August 16, 2021
• Primary Completion: December 21, 2021
• Study Completion: December 21, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

US (1)