A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B
NCT ID: NCT06425341
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
369 participants
INTERVENTIONAL
2024-06-06
2027-01-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HRS-5635 Injection dose 1
HRS-5635 Injection
HRS-5635 Injection low dose administered by subcutaneous injection
HRS-5635 Injection dose 2
HRS-5635 Injection
HRS-5635 Injection medium dose administered by subcutaneous injection
HRS-5635 Injection dose 3
HRS-5635 Injection
HRS-5635 Injection high dose administered by subcutaneous injection
HRS-5635 Injection dose 4
HRS-5635 Injection
HRS-5635 Injection lowest dose administered by subcutaneous injection
HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection
HRS-5635 Injection (low dose) and Peg-IFN-α
HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection
HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection
HRS-5635 Injection (high dose) and Peg-IFN-α
HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection
Peg-IFN-α, administered by subcutaneous injection
Peg-IFN-α
Peg-IFN-α, administered by subcutaneous injection
HRS-5635 Injection with Peg-IFN-α（Part C）
HRS-5635 Injection with Peg-IFN-α
HRS-5635 Injection and Peg-IFN-α, administered by subcutaneous injection
HRS-5635 Injection（Part D）
HRS-5635 Injection
HRS-5635 Injection, administered by subcutaneous injection
Interventions
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HRS-5635 Injection
HRS-5635 Injection low dose administered by subcutaneous injection
HRS-5635 Injection
HRS-5635 Injection medium dose administered by subcutaneous injection
HRS-5635 Injection
HRS-5635 Injection high dose administered by subcutaneous injection
HRS-5635 Injection
HRS-5635 Injection lowest dose administered by subcutaneous injection
HRS-5635 Injection (low dose) and Peg-IFN-α
HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection
HRS-5635 Injection (high dose) and Peg-IFN-α
HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection
Peg-IFN-α
Peg-IFN-α, administered by subcutaneous injection
HRS-5635 Injection with Peg-IFN-α
HRS-5635 Injection and Peg-IFN-α, administered by subcutaneous injection
HRS-5635 Injection
HRS-5635 Injection, administered by subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
2. Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening;
3. Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation;
4. On commercially available NAs monotherapy for at least 24 weeks before randomization, and the dosing regimen remained unchanged for at least 4 weeks before randomization;
5. Need to take effective contraceptive measures；
6. Volunteer to sign an informed consent.
Exclusion Criteria
2. With autoimmune disease;
3. History of solid organ transplantation or hematopoietic stem cell transplantation;
4. Clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;
5. Malignant tumors were diagnosed within 5 years prior to randomization；
6. Infection requiring intervention within 2 weeks prior to randomization;
7. Major trauma or major surgery within the 12 weeks prior to randomization, or surgical plans or other treatment during the study period which the investigators determined may influence the evaluation of the study results;
8. Laboratory tests during the screening period were obviously abnormal;
9. Prolonged ECG QTcF or other clinically significant abnormal results that may pose a significant safety risk to the subject during the screening period;
10. History of drug use, alcohol or drug abuse in the 12 months prior to randomization;
11. Participated in clinical study of other drugs (received experimental drugs);
12. Pregnant or nursing women;
13. Allergic to a drug ingredient or component;
14. Other reasons for ineligibility as judged by the investigators.
18 Years
ALL
No
Sponsors
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Fujian Shengdi Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Nanfang Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HRS-5635-201
Identifier Type: -
Identifier Source: org_study_id
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