Chronic Hepatitis B
Conditions
Brief summary
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.
Interventions
DRUGHRS-5635
50mg HRS-5635；100mg HRS-5635；200mg HRS-5635；400mg HRS-5635；600mg HRS-5635；800mg HRS-5635
DRUGPlacebo
Placebo
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Understand the specific process of the test, voluntarily participate in the test, and sign the informed consent form in writing（In healthy people and chronic hepatitis B）. 2. Age 18-55 (including boundary value) （In healthy people）; Age 18-65 (including boundary value) （In chronic hepatitis B）. 3. Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) 18\ 28 kg/m2 (including boundary value) （In healthy people）. 4. Normal or abnormal vital signs, physical examination, laboratory examination, chest radiograph, etc. have no clinical significance（In healthy people）. 5. Subjects (including partners) are willing to voluntarily take effective contraceptive measures within 6 months after screening and the last study drug administration（In healthy people）.
Exclusion criteria
1. Those suffering from any clinical serious disease such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormality, or any other disease that can interfere with the test results（In healthy people）. 2. Previous history of malignant tumor（In healthy people）. 3. Those who have digestive system disease or serious digestive system disease at present or in the near future (within one month), and the researcher believes that it may affect drug absorption or have safety risk（In healthy people）. 4. Those who have serious infection, serious injury or major surgery within 3 months before administration; Those who plan to undergo surgery during the trial and within two weeks after the end of the trial（In healthy people）. 5. Serious cardiovascular and cerebrovascular diseases with clinical significance and unstable or uncontrolled conditions, including but not limited to myocardial infarction, unstable angina pectoris, heart failure, and moderate stroke（（In chronic hepatitis B））. 6. Clinically significant liver diseases caused by other causes (such as alcoholic liver disease, nonalcoholic steatohepatitis, drug-induced liver injury, alcoholic hepatitis, etc.); （In chronic hepatitis B）.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events In Part 1 | 85 days | A summary of adverse events, including Serious Adverse Events(SAEs) |
| Number of Adverse Events In Part 2 | 169 days | A summary of adverse events, including Serious Adverse Events(SAEs) |
Secondary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax) of single dose | 8 days |
| Peak Plasma Concentration (Cmax) of Multiple ascending dose | 64 days |
| Time to the peak plasma concentration (Tmax) of single dose | 8 days |
| Time to the peak plasma concentration (Tmax) of Multiple ascending dose | 64 days |
Countries
China
Contacts
Primary ContactGuangming Feng
Outcome results
None listed