NCT07606950

Brief Summary

This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and immunogenicity of HRS-5635 injection as compared to the placebo arm in nucleos(t)ide analogue-suppressed HBeAg-negative patients with chronic hepatitis B. The total duration of the study, including screening (up to 4 weeks), the double-blind treatment stage (60 weeks)，NAs-only treatment stage（12 weeks） and the off-treatment follow-up (24 weeks), is up to approximately 100 weeks at maximum for each participant.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
540

participants targeted

Target at P75+ for phase_3

Timeline
22mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jul 2026Jun 2028

First Submitted

Initial submission to the registry

May 19, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 17, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

July 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1.9 years

First QC Date

May 19, 2026

Last Update Submit

July 23, 2026

Conditions

Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • Percentage of participants with sustained HBV DNA suppression and HBsAg loss within 24 weeks after discontinuation of all HBV therapy

    24 weeks after discontinuation of all CHB treatment

Secondary Outcomes (15)

  • Percentage of participants with sustained HBV DNA suppression and HBsAg < 100 IU/mL

    Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment

  • Percentage of participants with sustained HBV DNA suppression and HBsAg < 10 IU/mL

    Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment

  • Percentage of participants with sustained HBV DNA suppression

    Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment

  • Percentage of participants with HBsAg < 100 IU/mL

    Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment

  • Percentage of participants with HBsAg < 10 IU/mL

    Pre-specified time points up to 24 weeks after discontinuation of all CHB treatment

  • +10 more secondary outcomes

Study Arms (2)

HRS-5635 Injection

EXPERIMENTAL
Drug: HRS-5635 Injection

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

HRS-5635 InjectionDRUG

HRS-5635 Injection, administered by subcutaneous injection;

HRS-5635 Injection
PlaceboDRUG

Placebo, administered by subcutaneous injection.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening;
  • Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation;
  • HBeAg negative at screening;
  • 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;
  • Need to take effective contraceptive measures；
  • Volunteer to sign an informed consent.

You may not qualify if:

  • 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;
  • With autoimmune disease;
  • History of solid organ transplantation or hematopoietic stem cell transplantation;
  • Clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;
  • Malignant tumors were diagnosed within 5 years prior to randomization；
  • 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;
  • Laboratory tests during the screening period were obviously abnormal;
  • Prolonged ECG QTcF or other clinically significant abnormal results that may pose a significant safety risk to the subject during the screening period;
  • History of drug use, alcohol or drug abuse in the 12 months prior to randomization;
  • Participated in clinical study of other drugs (received experimental drugs);
  • Pregnant or nursing women;
  • Allergic to a drug ingredient or component;
  • Other reasons for ineligibility as judged by the investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangzhou, 510515, China

RECRUITING

Central Study Contacts

Xiaopeng Wang

CONTACT

0518-82342973xiaopeng.wang@hengrui.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2026

First Posted

May 26, 2026

Study Start

July 17, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

July 24, 2026

Record last verified: 2026-03

Locations

CN(1)