NASH - Nonalcoholic SteatohepatitisPhase 1NCT05022693
PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis
A Phase 1 study testing BIO89-100 in people with NASH - Nonalcoholic Steatohepatitis, run by 89bio, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- BIO89-100
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2021to 21 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Being tested
- BIO89-100
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIO89-100Drug
Subcutaneous Injections
| Study group | Role | What they receive |
|---|---|---|
| BIO89-100 30 mg, Open Lable, Single Dose | Experimental | Not described Receives: Drug: BIO89-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK Profile of liquid formulation of BIO89-100
Determine maximum observed serum drug concentration (Cmax)
Measured: 22 days
PK Profile of liquid formulation of BIO89-100
Area under the serum drug concentration-by-time curve from time 0 to the time of the last quantifiable drug concentration (AUC0-t)
Measured: 22 days
Secondary outcomes (1)
Evaluate the safety and tolerability of the BIO89-100 liquid formulation
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
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start16 Aug 2021
- Primary completion21 Dec 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, single dose, PK study
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- 89bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022693
- Sponsor's protocol ID
- BIO89-100-111
- Status last verified
- Feb 2022
- First submitted
- 20 Aug 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05022693
- Acronym / sponsor ID
- BIO89-100-111
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- 89bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, single dose, PK study
| Arm | Type | Receives |
|---|---|---|
| BIO89-100 30 mg, Open Lable, Single Dose | Experimental | Drug: BIO89-100 |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIO89-100Subcutaneous Injections | Drug | BIO89-100 30 mg, Open Lable, Single Dose |
Primary outcome
PK Profile of liquid formulation of BIO89-100
Time frame: 22 days
Determine maximum observed serum drug concentration (Cmax)
PK Profile of liquid formulation of BIO89-100
Time frame: 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)
1 secondary outcome
Evaluate the safety and tolerability of the BIO89-100 liquid formulation
Time frame: 22 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIO89-100 in people with NASH - Nonalcoholic Steatohepatitis, run by 89bio, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK Profile of liquid formulation of BIO89-100 (time frame: 22 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.