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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06425341
Other study ID # HRS-5635-201
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
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