The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-5635 in healthy adults and chronic hepatitis B. To explore the reasonable dosage of HRS-5635.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
85
50mg HRS-5635;100mg HRS-5635;200mg HRS-5635;400mg HRS-5635;600mg HRS-5635;800mg HRS-5635
100mg HRS-5635,Q4W;200mg HRS-5635 ,Q4W;400mg HRS-5635,Q4W;200mg HRS-5635, Q2W
200mg HRS-5635,Q4W
Placebo
The First Affiliated Hospital of China University of Science and Technology
Hefei, Anhui, China
RECRUITINGNumber of Adverse Events In Part 1
A summary of adverse events, including Serious Adverse Events(SAEs)
Time frame: 85 days
Number of Adverse Events In Part 2
A summary of adverse events, including Serious Adverse Events(SAEs)
Time frame: 169 days
Peak Plasma Concentration (Cmax) of single dose
Time frame: 8 days
Peak Plasma Concentration (Cmax) of Multiple ascending dose
Time frame: 64 days
Time to the peak plasma concentration (Tmax) of single dose
Time frame: 8 days
Time to the peak plasma concentration (Tmax) of Multiple ascending dose
Time frame: 64 days
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