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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
8
Subcutaneous Injections
89bio Clinical Study Site
Chandler, Arizona, United States
PK Profile of liquid formulation of BIO89-100
Determine maximum observed serum drug concentration (Cmax)
Time frame: 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)
Time frame: 22 days
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
Time frame: 22 days
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