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
- Registration Number
- NCT05808374
- Lead Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 85
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）.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 2b Placebo Patients not receiving consolidation treatment：HRS-5635 vs. Placebo Part 2b HRS-5635 Patients not receiving consolidation treatment：HRS-5635 vs. Placebo Part 1 HRS-5635 Single Dose Incremental (SAD) Trial - Healthy Persons：HRS-5635 vs. Placebo Part 1 Placebo Single Dose Incremental (SAD) Trial - Healthy Persons：HRS-5635 vs. Placebo Part 2a HRS-5635 Multiple Dose Increase (MAD) Study - Patients Receiving Consolidation Therapy：HRS-5635 vs. Placebo Part 2a Placebo Multiple Dose Increase (MAD) Study - Patients Receiving Consolidation Therapy：HRS-5635 vs. Placebo
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
The First Affiliated Hospital of China University of Science and Technology
🇨🇳Hefei, Anhui, China