This is an open label study that will be conducted at a single site in China to evaluate the safety,tolerability and PK/PD profile of multiple dose of recombinant human serum albumin/interferon alpha2a fusion protein in chronic hepatitis B patients.The total duration of study participation is up to 22 weeks for each subject,including 4 weeks screening period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
600,750 or 900 mcg dosing every 2 weeks
180 mcg dosing every week
Jilin University First Affiliated Hospital
Changchun, Jilin, China
Number of adverse events
Time frame: 18 weeks
Decrease of HBV DNA
Time frame: 18 weeks
AUCss
Time frame: 18 weeks
Css_av
Time frame: 18 weeks
Css_min
Time frame: 18 weeks
Css-max
Time frame: 18 weeks
T1/2
Time frame: 18 weeks
Tmax
Time frame: 18 weeks
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