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

Last updated: July 10, 2025
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Hepatitis B

Hepatitis

Liver Disorders

Treatment

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

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

HRS-5635 Injection

Clinical Study ID

NCT06425341
HRS-5635-201
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 priorto screening;

  3. Virologically suppressed on nucleoside or nucleotide analogues treatment with HBVDNA below the lower limit of quantitation;

  4. On commercially available NAs monotherapy for at least 24 weeks beforerandomization, and the dosing regimen remained unchanged for at least 4 weeks beforerandomization;

  5. Need to take effective contraceptive measures;

  6. Volunteer to sign an informed consent.

Exclusion

Exclusion Criteria:

  1. History of cirrhosis or clinical evidence of hepatic decompensation, confirmed orsuspected liver cancer, with other liver diseases other than chronic hepatitis Bthat 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 andcerebrovascular 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, orsurgical plans or other treatment during the study period which the investigatorsdetermined 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 asignificant 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.

Study Design

Total Participants: 303
Treatment Group(s): 4
Primary Treatment: HRS-5635 Injection (high dose) and Peg-IFN-α
Phase: 2
Study Start date:
June 06, 2024
Estimated Completion Date:
January 19, 2027

Connect with a study center

  • Nanfang Hospital

    Guangzhou, Guangdong 510515
    China

    Active - Recruiting

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