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

NCT07519330 | Recruiting Phase 2

• 1 other identifier: HH006-202
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hepatitis B Virus Infection

Keywords

chronic hepatitis B virus infection

Outcome Measures

Primary Outcomes (1)

• HBsAg change from baseline

  value of HBsAg change from baseline

  week 24

Secondary Outcomes (21)

• HBsAg change from baseline

  week 12, week 48 of treatment and week 24 of follow up

• proportion of HBsAg loss

  week 24, week 48 of treatment and week 24 of follow up

• HBsAg change from baseline

  up to 72 weeks

• cohort 1and cohort 2: proportion of HBV DNA decreasing more than 1 log10/mL

  week 12, week 24, week 48 of treatment and week 24 of follow up

• proportion of HBV DNA < LLOQ

  week 12, week 24, week 48 of treatment and week 24 of follow up

Study Arms (3)

HH-006 Cohort 1

EXPERIMENTAL

untreated HBeAg-positive chronic HBV infected participants will receive HH-006

Biological: HH-006

HH-006 Cohort 2

EXPERIMENTAL

untreated HBeAg-negative chronic HBV infected participants will receive HH-006

Biological: HH-006

HH-006 Cohort 3

EXPERIMENTAL

participants with HBeAg-negative chronic HBV infection who have been treated with NAs for more than one year will receive HH-006

Biological: HH-006

Interventions

HH-006 BIOLOGICAL

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

HH-006 Cohort 1; HH-006 Cohort 2; HH-006 Cohort 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Sex: male or female; Age: 18 to 45 years old (inclusive);
• Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI): 18 kg/m² ≤ BMI ≤ 28 kg/m²;
• HBsAg and/or HBV DNA positivity for more than 6 months (including 6 months), or previous liver biopsy results indicating chronic hepatitis B, or negative for anti-HBc IgM;
• Virological and liver function indicators at screening:
• Cohort 1: HBeAg-positive, 2000 IU/mL ≤ HBsAg ≤ 100,000 IU/mL, HBV DNA \> 105 IU/mL, 2 × upper limit of normal (ULN) ≤ ALT ≤ 8 × ULN; Cohort 2: HBeAg-negative, 100 IU/mL ≤ HBsAg ≤ 3000 IU/mL, 20 IU/mL \< HBV DNA ≤ 2000 IU/mL, ALT ≤ 5 × ULN; Cohort 3: HBeAg-negative, 100 IU/mL ≤ HBsAg ≤ 3000 IU/mL, HBV DNA ≤ 100 IU/mL, ALT ≤ 2 × ULN;
• Previous antiviral treatment:
• Cohort 1 and Cohort 2: No interferon antiviral treatment within the past 1 year, and no nucleos(t)ide analogue (NA) treatment within the 6 months prior to screening; Cohort 3: No interferon antiviral treatment within the past 1 year; received only nucleos(t)ide analogue monotherapy for at least one year;
• Fully understand the study content, procedures, and possible adverse reactions, and sign the written informed consent form (ICF);
• Able to communicate effectively with the investigator and complete the study in accordance with the study requirements;
• Male subjects who have not undergone sterilization and female subjects who have been postmenopausal for less than two years must agree to take adequate and effective contraceptive measure from screening until the last follow-up visit.

You may not qualify if:

• Co-infected with hepatitis C, syphilis, or human immunodeficiency virus (HIV);
• At screening: total bilirubin ≥ 3 × ULN and direct bilirubin (DBil) \> 1 × ULN; hemoglobin \< 100 g/L; platelet count \< 100,000/mm³ (100 × 109/L); absolute neutrophil count \< 1,500/mm³ (1.5 × 109/L); serum albumin \< 35 g/L; prothrombin time international normalized ratio (INR) \> 1.3; glycated hemoglobin (HbA1c) ≥ 7%; estimated glomerular filtration rate (eGFR) (MDRD formula) \< 60 mL/min/1.73 m² (Appendix 2 MDRD calculation formula);
• Clinically significant electrocardiogram (ECG) abnormalities (e.g., QTcF \> 450 ms in males, \> 470 ms in females, severe arrhythmias such as torsade de pointes, paroxysmal ventricular tachycardia, symptomatic atrial fibrillation/flutter requiring emergency treatment, complete atrioventricular block); poorly controlled or refractory hypertension (e.g., systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg after medication use, etc.);
• Concurrent clinically significant other liver diseases, including but not limited to: moderate or severe fatty liver, alcoholic liver disease, autoimmune liver disease, hereditary metabolic liver disease, drug-induced liver injury, etc.;
• History of progressive hepatic fibrosis or cirrhosis at any time prior to or during screening;
• Current or prior history of hepatic decompensation manifestations, including but not limited to: ascites, hepatic encephalopathy, esophageal and gastric variceal bleeding, hepatorenal syndrome, etc.;
• Previous history of hepatocellular carcinoma, or at screening: serum alpha-fetoprotein (AFP) ≥ 50 ng/mL; or liver ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI) findings suggestive of possible hepatocellular carcinoma;
• Circulatory system diseases: e.g., unstable angina, myocardial infarction, congestive heart failure, etc.;
• Respiratory system diseases: e.g., severe chronic obstructive pulmonary disease, etc.;
• Primary or secondary kidney diseases (e.g., chronic renal decompensation, renal diseases secondary to diabetes, hypertension, vascular diseases, etc.);
• Endocrine system diseases: e.g., poorly controlled diabetes or thyroid diseases, etc.;
• Autoimmune diseases: e.g., systemic lupus erythematosus, primary immune thrombocytopenia, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, autoimmune hemolytic anemia, severe psoriasis, etc.;
• Neuropsychiatric disorders: e.g., epilepsy, schizophrenia, depression, etc.;
• Malignant tumors;
• Lactating women or those with a positive pregnancy test;

Sponsors & Collaborators

• Huahui Health: lead

Study Sites (1)

Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiaoping Chen PM

CONTACT

+86 18518676059; chenxiaoping@hhhbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: May 14, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): March 22, 2028
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

CN (1)