A Study to Evaluate the Antiviral Activity and Immune Response of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)

Ausper Biopharma

Status and phase

Enrolling

Phase 2

Conditions

Chronic Hepatitis B

Treatments

Drug: AHB-137

Study type

Interventional

Funder types

Industry

Identifiers

NCT06993480

AB-10-8005

Details and patient eligibility

About

AB-10-8005 is a single-center, open-label Phase II clinical study to evaluate the antiviral activity and immune responses of AHB-137 injection in participants with CHB treated with nucleos (t) ide analogues.

Full description

The study is to evaluate the antiviral activity and immune response of AHB-137 injection in participants with CHB treated with nucleos(t)ide analogues. The study is proposed to enroll 20-30 patients, with a total study duration of approximately 56 weeks per participants, including a screening period (up to 4 weeks), a clinical study lead-in period (approximately 4 weeks), an AHB-137 treatment period (24 weeks) and a follow-up period (24 weeks).

Enrollment

30 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Voluntarily participated in the study and signed an informed consent form;
Aged between 18 and 55 years at the time of signing the informed consent form;
Body mass index (BMI) within the range of 18-30 kg/ m2;
HBeAg negative or positive at screening;
HBsAg or HBV DNA positive for at least 6 months;
Have been on continuous nucleos(t)ide analogues antiviral therapy for more than 6 months prior to screening;
100 IU/mL < HBsAg ≤ 3000 IU/mL and HBV DNA < 100 IU/mL at screening;
Alanine aminotransferase (ALT) ≤ 2 × upper limit of normal (ULN);
Effective contraception as required.

Exclusion criteria

Clinically significant abnormalities other than a history of CHB infection;
Concomitant clinically significant other liver diseases;
Any serious infection other than CHB infection requiring intravenous anti-infective therapy within 1 month prior to screening;
Active hepatitis C, Human immunodeficiency virus (HIV) positive, syphilis positive;
Liver stiffness value (LSM) > 9.0 kPa at screening;
Diagnosis or suspicion of hepatocellular carcinoma, or alpha-fetoprotein (AFP) concentration ≥ 20 ng/mL at screening;
Participants with confirmed or suspected hepatic decompensated hepatitis B cirrhosis;
Liver biopsy at screening assessed severity of activity ≥ G3 grade and/or fibrosis reaching S4 stage;
History of extrahepatic disease possibly related to HBV immune status;
Ongoing or taking any immunosuppressive medication within 3 months prior to screening. Those who have used immunomodulators and cytotoxic drugs within 6 months prior to the first dose, or have a history of vaccination within 1 month prior to screening or have a live vaccination plan during the trial; Continuous use of traditional Chinese medicine for more than 2 months within 1 year prior to screening, or within 1 month prior to screening; Ongoing use of anticoagulants, bleeding tendency or coagulopathy, or conditions that, in the opinion of the investigator, increase the risk of liver biopsy;
Receiving or using any interferon-containing therapy within 12 months prior to screening;
History of malignancy within 5 years prior to screening or being evaluated for possible malignancy;
Suspected history of allergy to any component of the study drug, or allergic constitution (multiple drug and food allergy, and judged by the investigator to be clinically significant);
Major trauma or major surgery within 3 months prior to screening, or planned surgery during the study;
Donation or blood loss ≥ 400 mL, or received blood transfusion within 12 weeks prior to screening; Or blood donation or blood loss ≥ 200 mL within 1 month prior to screening;
Participants who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
Received any antisense oligonucleotides (ASO) or using any small molecule interfering ribonucleic acid (siRNA) drug within 12 months prior to screening;
Participants with abnormal thyroid function judged by the investigator to be ineligible for enrollment;
Obviously abnormal laboratory test results;
History of vasculitis or signs and symptoms of underlying vasculitis;
Any other circumstance or condition that, in the opinion of the investigator, the participants are inappropriate for participation in the study.