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Completed

NCT Number: NCT05022693

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

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Key information

Conditions

NASH - Nonalcoholic Steatohepatitis Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

89bio Clinical Study Site

Chandler, Arizona, 85224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BIO89-100

Drug

Subcutaneous Injections

Primary outcomes

  1. PK Profile of liquid formulation of BIO89-100

    Time frame: 22 days

    Determine maximum observed serum drug concentration (Cmax)

  2. PK Profile of liquid formulation of BIO89-100

    Time frame: 22 days

    Area under the serum drug concentration-by-time curve from time 0 to the time of the last quantifiable drug concentration (AUC0-t)

Secondary outcomes

  1. Evaluate the safety and tolerability of the BIO89-100 liquid formulation

    Time frame: 22 days

    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

Sponsors and collaborators

Lead sponsor

89bio, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 26, 2021
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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