The Safety, Tolerability, Pharmacokinetics and antiviral activity Study of Anti hepatitis B virus treatment drug Freethiadine in Healthy subjects and in patients with chronic hepatitis B
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
128
Subjects will receive either a single dose of Freethiadine on Day 1 only (SAD HV), twice daily dosing of Freethiadine starting on Day 1 through Day 10 (MAD HV)
once or twice daily for consecutive 28 days
Subjects will receive either a single dose of Freethiadine on Day 1 only (SAD HV), twice daily dosing of Freethiadine starting on Day 1 through Day 10 (MAD HV)
Southern Hospital of Southern Medical University
Guangzhou, Guangdong, China
The First Hospital of Jilin University
Changchun, Jilin, China
Adverse Events
Incidence of adverse events
Time frame: From Days 1-35
AUC
Maximum plasma concentration of study drugs
Time frame: Day 1-12
HBV DNA
Change from baseline in HBV DNA
Time frame: Day 1-35
HBsAg
Change from baseline in HBsAg
Time frame: Day 1-35
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once daily for consecutive 28 days