Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-01-03 @ 3:57 AM
Study NCT ID:
NCT05022693
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2021-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis
Sponsor:
89bio, Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: