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

Phase 1
Completed
Conditions
NASH - Nonalcoholic Steatohepatitis
Interventions
Drug: BIO89-100
Registration Number
NCT05022693
Lead Sponsor
89bio, Inc.
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
8
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

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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
BIO89-100 30 mg, Open Lable, Single DoseBIO89-100-
Primary Outcome Measures
NameTimeMethod
PK Profile of liquid formulation of BIO89-10022 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 Outcome Measures
NameTimeMethod
Evaluate the safety and tolerability of the BIO89-100 liquid formulation22 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

Trial Locations

Locations (1)

89bio Clinical Study Site

🇺🇸

Chandler, Arizona, United States

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