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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: Completed Phase 1 study of NASH - Nonalcoholic Steatohepatitis, sponsored by 89bio.
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 262-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Determine maximum observed serum drug concentration (Cmax)
Conditions Studied
Interventions
- DRUG BIO89-100
Study Locations (1)
Arizona
- 89bio Clinical Study Site - Chandler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-08-16 |
| Est. Completion | 2021-12-21 |
| Phase | Phase 1 |
What the finished NCT05022693 record still lists
NCT05022693 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 262-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05022693's enrollment target sits among peer trials
8 28th of 28 higher than 1 of 28 other NASH - Nonalcoholic Steatohepatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NASH - Nonalcoholic Steatohepatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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