Phase
Condition
Hepatitis
Hepatitis B
Liver Disorders
Treatment
AHB-137
Placebo
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants voluntarily participate in the study, and sign the Informed ConsentForm (ICF) prior to screening, able to complete the study according to the protocol;
Male or female participants aged 18-65 years old (including the boundary value) atthe time of signing the ICF;
Male participants weighed higher than 50kg and female participants weighted higherthan 50 kg, Body Mass Index (BMI) between 18 to 32 kg/m^2(inclusive);
Participants with positive HBsAg or HBV DNA greater than or equal to (≥) 6 monthsprior to screening and has not received antiviral treatment with interferon ornucleos(t)ide analogue ;
At screening, 20 IU/mL<HBV DNA≤2000 IU/mL;
At screening, 100 IU/mL<HBsAg≤10000 IU/mL;
At screening, ALT<3×upper limit of normal (ULN);
For women with childbearing potential should be non-pregnant or non-lactating duringscreening, and participants are willing to take effective contraceptive measuresfrom the screening until the last visit or at least 6 months after the last dosing.
Exclusion
Exclusion Criteria:
Clinically significant abnormalities except chronic HBV infection;
Any clinically significant liver diseases, including but not limited to hepatitiscaused by other pathogenic infections, hemochromatosis, Wilson disease, primarybiliary cirrhosis, autoimmune liver diseases, alcoholic liver disease, severenon-alcoholic fatty liver disease, Imaging-diagnosed moderate to severe fatty liver,drug-induced liver injury, history of hereditary liver disease, etc.;
Participants with severe infection requiring systemic anti-infection treatment 1month before randomization;
Co-infection with current or past history of Hepatitis C virus (HCV), Humanimmunodeficiency virus (HIV), Hepatitis D virus (HDV).
Participants who have had or currently have cirrhosis or currently have progressiveliver fibrosis;
Participants who have had or currently have hepatobiliary system tumor; Or bloodalpha-fetoprotein (AFP) ≥ 20 ng/mL during screening, or the liver B-ultrasound, CT,MRI and other imaging examinations suggested the possibility of hepatobiliary systemtumors;
The laboratory examination results are obviously abnormal;
History of vasculitis or signs and symptoms of potential vasculitis;
Anti-neutrophil cytoplasmic antibodies (ANCA) was positive at screening.
History of extrahepatic disease that may be related to HBV immune status;
Administration of immunosuppressants within 3 months prior to screening, except forshort-term use (≤2 weeks) or topical/inhaled steroids. Administration ofimmunomodulators (thymosin) and cytotoxic drugs within 6 months prior to the firststudy intervention or have a history of vaccination within 1 month prior toscreening or planned administration during the study;
History of malignancy within the past 5 years or the discovery of suspected tumorsduring the screening period;
Any suspicion of drug component allergy, or allergic constitution (various drug andfood allergy, and judged by the investigator to be clinically significant) inparticipants;
Participants who have significant trauma or major surgery within 3 months beforescreening, or plan to perform surgery during the study;
Blood donation or blood loss more than 400 mL within 12 weeks before screening;Blood transfusion; Blood donation or blood loss not less than 200 mL within 1 monthbefore screening;
Concurrently participating in another clinical study, or received an investigationalproduct within the following time period prior to the first dosing day in thecurrent study: 5 half-lives or twice the duration of the biological effect of thestudy treatment or 90 days, whichever is longer;
Participants who have received any oligonucleotide or small molecule interferingribonucleic acid (siRNA) drugs;
Any other circumstances or conditions for which the investigator considers that theparticipants are inappropriate to participate in the study.
Study Design
Connect with a study center
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing 401336
ChinaActive - Recruiting
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian
ChinaActive - Recruiting
The Third People's Hospital of Zhenjiang
Zhenjiang, Jiangsu
ChinaActive - Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310052
ChinaActive - Recruiting
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