Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of Single Administration of HRS-5635 Injection in Chinese Healthy Subjects and the Safety, Tolerance, Pharmacokinetics and Antiviral Effect of Multiple Administration in Patients With Chronic Hepatitis B

Study Overview
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Brief Summary
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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.

Official Title
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Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of Single Administration of HRS-5635 Injection in Chinese Healthy Subjects and the Safety, Tolerance, Pharmacokinetics and Antiviral Effect of Multiple Administration in Patients With Chronic Hepatitis B

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: HRS-5635
* Drug: HRS-5635
* Drug: HRS-5635
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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）. Age 18-55 (including boundary value) （In healthy people）; Age 18-65 (including boundary value) （In chronic hepatitis B）. Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) 18 28 kg/m2 (including boundary value) （In healthy people）. Normal or abnormal vital signs, physical examination, laboratory examination, chest radiograph, etc. have no clinical significance（In healthy people）. 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: 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）. Previous history of malignant tumor（In healthy people）. 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）. 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）. 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））. 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）.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br>Single Dose Incremental (SAD) Trial - Healthy Persons：HRS-5635 vs. Placebo | Drug: HRS-5635<br>* 50mg HRS-5635；100mg HRS-5635；200mg HRS-5635；400mg HRS-5635；600mg HRS-5635；800mg HRS-5635<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: Part 2a<br>Multiple Dose Increase (MAD) Study - Patients Receiving Consolidation Therapy：HRS-5635 vs. Placebo | Drug: HRS-5635<br>* 100mg HRS-5635，Q4W；200mg HRS-5635 ，Q4W；400mg HRS-5635，Q4W；200mg HRS-5635, Q2W<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: Part 2b<br>Patients not receiving consolidation treatment：HRS-5635 vs. Placebo | Drug: HRS-5635<br>* 200mg HRS-5635，Q4W<br>Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events In Part 1 | A summary of adverse events, including Serious Adverse Events(SAEs) | 85 days | 
| Number of Adverse Events In Part 2 | A summary of adverse events, including Serious Adverse Events(SAEs) | 169 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |