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
Group Intervention Description BIO89-100 30 mg, Open Lable, Single Dose BIO89-100 -
- Primary Outcome Measures
Name Time Method PK Profile of liquid formulation of BIO89-100 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 Outcome Measures
Name Time Method Evaluate the safety and tolerability of the BIO89-100 liquid formulation 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
Trial Locations
- Locations (1)
89bio Clinical Study Site
🇺🇸Chandler, Arizona, United States