Back to resultsPK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis
Primary Purpose
NASH - Nonalcoholic Steatohepatitis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BIO89-100
Sponsored by
About this trial
This is an interventional other trial for NASH - Nonalcoholic Steatohepatitis
Eligibility Criteria
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.
Sites / Locations
- 89bio Clinical Study Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BIO89-100 30 mg, Open Lable, Single Dose
Arm Description
Outcomes
Primary Outcome Measures
PK Profile of liquid formulation of BIO89-100
Determine maximum observed serum drug concentration (Cmax)
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)
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05022693
Brief Title
PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis
Official Title
An Open-Label, Single-Dose Pharmacokinetic Study of Liquid Subcutaneous Formulation of BIO89-100 in Subjects With Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
December 21, 2021 (Actual)
Study Completion Date
December 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
89bio, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH - Nonalcoholic Steatohepatitis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Open label, single dose, PK study
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIO89-100 30 mg, Open Lable, Single Dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BIO89-100
Intervention Description
Subcutaneous Injections
Primary Outcome Measure Information:
Title
PK Profile of liquid formulation of BIO89-100
Description
Determine maximum observed serum drug concentration (Cmax)
Time Frame
22 days
Title
PK Profile of liquid formulation of BIO89-100
Description
Area under the serum drug concentration-by-time curve from time 0 to the time of the last quantifiable drug concentration (AUC0-t)
Time Frame
22 days
Secondary Outcome Measure Information:
Title
Evaluate the safety and tolerability of the BIO89-100 liquid formulation
Description
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
Time Frame
22 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
89bio Clinical Study Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
12. IPD Sharing Statement
Learn more about this trial
PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis
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