A Study to Evaluate the Antiviral Activity and Safety of HH-003 in Chronic Hepatitis B Subjects With Low-level Viremia

Huahui Health

Status and phase: Completed; Phase 2

Conditions: Chronic HBV Infection

Treatments: Drug: HH-003, NrtIs and PEG-IFN-α; Drug: Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs); Drug: HH-003 and NrtIs

Study type: Interventional

Funder types: Industry

Identifiers

NCT05734807

HH003-203

Details and patient eligibility

About

This is a multicenter, randomized, controlled Phase IIa study of HH-003 to evaluate the antiviral activity and safety in nucleos(t)ide analogues-treated chronic hepatitis B subjects with low-level viremia. HH-003 is a human monoclonal antibody targeting the pre-S1 domain of the HBV large envelope protein. It blocks engagement of preS1 with sodium taurocholate co-transporting polypeptide (NTCP), the cellular receptor for HBV.

Enrollment: 74 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent form;
• Male or female aged from 18 to 60 years (inclusively);
• 18 kg/m^2≤BMI≤30 kg/m^2, body weight≥50 kg for men and ≥45 kg for women;
• Subjects who have chronic HBV infection greater than or equal to 6 months at screening;
• 10 IU/mL≤HBsAg≤3000 IU/mL; HBV DNA≤2000 IU/mL; ALT≤3×ULN;
• Subjects who have been on nucleoside reverse transcriptase inhibitors therapy for more than 1 year prior to screening.

Exclusion criteria

• Females who are pregnant or lactating at screening;
• History of alcoholic liver disease, moderate fatty liver, autoimmune liver disease, other hereditary liver disease, drug-induced liver disease or other clinically significant chronic liver disease induced by non-HBV infection;
• History of cirrhosis at any time prior to or at time of screening, or having progressive liver fibrosis at screening ;
• History or evidence of hepatocellular carcinoma at any time prior to or at time of screening;
• Exclusionary laboratory results at screening: total bilirubin >2xULN or direct bilirubin >1.5xULN，hemoglobin <120 g/L for males or <110 g/L ro females，platelets count<100,000/mm^3 (100×10^9/L), and absolute neutrophils count <1,500/mm^3 (1.5×10^9/L).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 3 patient groups

NrtIs

Active Comparator group

Treatment:

Drug: Nucleoside/nucleotide reverse transcriptase inhibitors (NrtIs)

HH-003+NrtIs

Experimental group

Treatment:

Drug: HH-003 and NrtIs

HH-003+NrtIs+PEG-IFN-α

Experimental group

Treatment:

Drug: HH-003, NrtIs and PEG-IFN-α