NCT07519330

Clinical Study to Evaluate the Efficacy and Safety of HH-006 in Patients With Chronic Hepatitis B Virus Infection

Phase II Clinical Study to Evaluate the Efficacy and Safety of Multiple Dosing of HH-006 in Patients With Chronic Hepatitis B Virus Infection

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Huahui Health · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Study HH006-202 is designed to assesses the efficacy and safety of HH-006 in adults chronic HBV infection. Eligible participants will receive study treatment for 48 weeks. All treated patients will also undergo a follow-up period after last study drug treatment.

Detailed description

This is a multicenter, open-label Phase II clinical study, It aims to evaluate the efficacy, safety, and tolerability of HH-006 in untreated HBeAg-positive/negative chronic HBV infected individuals and those with HBeAg-negative chronic HBV infection who have been treated with NAs for more than one year. Study participants will undergo various screening examinations as per the protocol before enrollment. Eligible participants will be assigned to Cohort 1, Cohort 2, or Cohort 3 according to different inclusion and exclusion criteria (see Inclusion/Exclusion Criteria for details). Upon entering the study, participants in all cohorts will start a 4-week loading dose period of HH-006 480 mg QW, followed by HH-006 240 mg QW for 44 weeks. Participants in Cohort 3 will continue their pre-existing NAs therapy after enrollment. Evaluations will include changes in HBsAg/HBV DNA/ALT and safety.

Conditions

• Chronic Hepatitis B Virus Infection

Interventions

Type	Name	Description
BIOLOGICAL	HH-006	HH-006 480 mg SC injection every one week for 4 weeks and followed by 240 mg QW for 44 weeks

Timeline

• Start date: 2026-04-29
• Primary completion: 2028-02-28
• Completion: 2028-03-22
• First posted: 2026-04-09
• Last updated: 2026-04-09