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NCT05022693 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of NASH - Nonalcoholic Steatohepatitis, sponsored by 89bio.

Completed
Registry status
Phase 1
Development phase
8
Enrollment target
1
Study location

NCT05022693 is a Phase 1 study of NASH - Nonalcoholic Steatohepatitis that has completed, run by 89bio. The registered enrollment target is 8 participants, below the 269-participant average among 27 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05022693, a Phase 1 study of NASH - Nonalcoholic Steatohepatitis, has completed, sponsored by 89bio.

COMPLETED
Registry status
Phase 1
Development phase
8 participants
Enrollment target
1
Study location

Study 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

  • DRUG BIO89-100

Study Locations (1)

Arizona

  • 89bio Clinical Study Site - Chandler

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2021-08-16
Est. Completion 2021-12-21
Phase Phase 1

Sponsor

89bio

7 total trials

What the Registry Record Tells You About NCT05022693

The ClinicalTrials.gov registry entry for NCT05022693 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 269-participant average among 27 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (97% lower). The listed sponsor is 89bio, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with NASH - Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 1 intervention - of which BIO89-100 is the first listed.

NCT05022693 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.

Frequently Asked Questions

What is clinical trial NCT05022693 about?

NCT05022693 is a clinical study titled "PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis". 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.

What is the current status of trial NCT05022693?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2021-08-16. Estimated completion is 2021-12-21.

What conditions does trial NCT05022693 study?

This clinical trial studies the following conditions: NASH - Nonalcoholic Steatohepatitis.

What interventions are being tested in trial NCT05022693?

The interventions under investigation include: BIO89-100 (DRUG).

Who is sponsoring clinical trial NCT05022693?

This trial is sponsored by 89bio, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05022693 being conducted?

This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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