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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06425341
• Other study ID #: HRS-5635-201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2024
• Est. completion date: September 19, 2026

Study information

• Verified date: May 2024
• Source: Fujian Shengdi Pharmaceutical Co., Ltd.
• Contact: Xiaopeng Wang
• Phone: 0518-82342973
• Email: xiaopeng.wang[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 165
• Est. completion date: September 19, 2026
• Est. primary completion date: May 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Nanfang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Shengdi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PartA:Change in mean log10 serum hepatitis B surface antigen levels from baseline at week 12		Week 12
Primary	PartB:Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48		Week 48
Secondary	Changes from baseline in mean log10 serum hepatitis B surface antigen levels		Pre-specified time points up to 72 weeks
Secondary	Proportion of subjects with at least one log10 decline from baseline in serum hepatitis B surface antigen		Pre-specified time points up to 72 weeks
Secondary	Proportion of subjects with serum hepatitis B surface antigen loss		Pre-specified time points up to 72 weeks
Secondary	Proportion of subjects with serum hepatitis B surface antigen seroconversion		Pre-specified time points up to 72 weeks
Secondary	Proportion of subjects with hepatitis B e-antigen loss		Pre-specified time points up to 72 weeks
Secondary	Proportion of subjects with serum hepatitis B e-antigen seroconversion		Pre-specified time points up to 72 weeks
Secondary	Proportion of subjects with virologic breakthrough		Pre-specified time points up to 72 weeks
Secondary	Proportion of subjects with drug resistance		Pre-specified time points up to 72 weeks