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

Fujian Shengdi Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: HRS-5635; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05808374

HRS-5635-101

Details and patient eligibility

About

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.

Enrollment: 85 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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）.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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85 participants in 3 patient groups

Part 1

Experimental group

Description:

Single Dose Incremental (SAD) Trial - Healthy Persons：HRS-5635 vs. Placebo

Treatment:

Drug: Placebo

Drug: HRS-5635

Drug: HRS-5635

Drug: HRS-5635

Part 2a

Experimental group

Description:

Multiple Dose Increase (MAD) Study - Patients Receiving Consolidation Therapy：HRS-5635 vs. Placebo

Treatment:

Drug: Placebo

Drug: HRS-5635

Drug: HRS-5635

Drug: HRS-5635

Part 2b

Experimental group

Description:

Patients not receiving consolidation treatment：HRS-5635 vs. Placebo

Treatment:

Drug: Placebo

Drug: HRS-5635

Drug: HRS-5635

Drug: HRS-5635