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

NCT05022693 — Phase 1, Completed, 8 participants, 89bio, Inc.

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

Registry	NCT05022693
Status	Completed
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, other
Enrollment	8 (Actual)
Sponsor	89bio, Inc. (Industry)
Conditions	NASH - Nonalcoholic Steatohepatitis
Interventions	BIO89-100 (Drug)
Dates	start 2021-08-16, primary completion 2021-12-21, completion 2021-12-21, first posted 2021-08-26, last updated 2022-03-02
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
BIO89-100 30 mg, Open Lable, Single Dose	Experimental	Drug: BIO89-100

BIO89-100 (Drug): Subcutaneous Injections

+Outcome measures

Primary outcomes

PK Profile of liquid formulation of BIO89-100 [22 days]: Determine maximum observed serum drug concentration (Cmax)
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 outcomes

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

+Eligibility

Sex: All, ages: 21 Years to 65 Years

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.

+Locations (1)

Facility	City	Country	Status
89bio Clinical Study Site	Chandler, Arizona	United States

My Notes

Public

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