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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIO89-100 30 mg, Open Lable, Single Dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIO89-100 | Drug | Subcutaneous Injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK Profile of liquid formulation of BIO89-100 | Determine maximum observed serum drug concentration (Cmax) | 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) | 22 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 22 days |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 89bio Clinical Study Site | Chandler | Arizona | 85224 | United States |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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Open label, single dose, PK study
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