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

Fujian Shengdi Pharmaceutical

Status and phase: Enrolling; Phase 2

Conditions: Chronic Hepatitis B

Treatments: Drug: HRS-5635 Injection (high dose) and Peg-IFN-α; Drug: HRS-5635 Injection (low dose) and Peg-IFN-α; Drug: Peg-IFN-α; Drug: HRS-5635 Injection with Peg-IFN-α; Drug: HRS-5635 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06425341

HRS-5635-201

Details and patient eligibility

About

A multicenter, randomized, open, parallel-designed Phase II 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.

Enrollment: 369 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Meet the body mass index standard greater than or equal to 18.5 kg/m2 and less than 35 kg/m2;
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

1. History of cirrhosis or clinical evidence of hepatic decompensation, confirmed or suspected liver cancer, with other liver diseases other than chronic hepatitis B that may affect the evaluation of the study;
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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369 participants in 9 patient groups, including a placebo group

HRS-5635 Injection dose 1

Experimental group

Treatment:

Drug: HRS-5635 Injection

Drug: HRS-5635 Injection

Drug: HRS-5635 Injection

Drug: HRS-5635 Injection

Drug: HRS-5635 Injection

HRS-5635 Injection dose 2

Experimental group

Treatment:

Drug: HRS-5635 Injection

Drug: HRS-5635 Injection

Drug: HRS-5635 Injection

Drug: HRS-5635 Injection

Drug: HRS-5635 Injection

HRS-5635 Injection dose 3

Experimental group

Treatment:

Drug: HRS-5635 Injection

Drug: HRS-5635 Injection

Drug: HRS-5635 Injection

Drug: HRS-5635 Injection

Drug: HRS-5635 Injection

HRS-5635 Injection dose 4

Experimental group

Treatment:

Drug: HRS-5635 Injection

Drug: HRS-5635 Injection

Drug: HRS-5635 Injection

Drug: HRS-5635 Injection

Drug: HRS-5635 Injection

HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection

Experimental group

Treatment:

Drug: HRS-5635 Injection (low dose) and Peg-IFN-α

HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection

Experimental group

Treatment:

Drug: HRS-5635 Injection (high dose) and Peg-IFN-α

Peg-IFN-α, administered by subcutaneous injection

Placebo Comparator group

Treatment:

Drug: Peg-IFN-α

HRS-5635 Injection with Peg-IFN-α（Part C）

Experimental group

Treatment:

Drug: HRS-5635 Injection with Peg-IFN-α

HRS-5635 Injection（Part D）

Experimental group

Treatment:

Drug: HRS-5635 Injection

Drug: HRS-5635 Injection

Drug: HRS-5635 Injection

Drug: HRS-5635 Injection

Drug: HRS-5635 Injection