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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05022693

Enrollment

Registered

2021-08-26

Start date

2021-08-16

Completion date

2021-12-21

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NASH - Nonalcoholic Steatohepatitis

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.

Interventions

DRUGBIO89-100

Subcutaneous Injections

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Intervention model description

Open label, single dose, PK study

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
PK Profile of liquid formulation of BIO89-100	22 days	Determine maximum observed serum drug concentration (Cmax)

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026