Phase
Condition
Hepatitis B
Hepatitis
Liver Disorders
Treatment
NAs
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 50 kg 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 or NAs ;
At screening, ALT<3×upper limit of normal (ULN);
Use effective contraception as required;
HBV DNA within the specified range at screening;
HBsAg was within the specified range at screening.
Exclusion
Exclusion Criteria:
Clinically significant abnormalities except chronic HBV infection;
Any clinically significant liver diseases;
Participants with severe infection requiring systemic anti-infection treatment 1month before enrollment;
Active hepatitis C, HIV antibody positive, treponema pallidum antibody positive;
Hepatobiliary neoplasm malignant;
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;
Those who are participating in another clinical trial, or have not undergone aprotocol-specified washout period prior to this study;
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
ChinaSite Not Available
The Second Affiliated Hospital of Chongqing Medical University
Chongqing 1814906, Chongqing Municipality 1814905 401336
ChinaSite Not Available
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian
ChinaSite Not Available
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou 1810821, Fujian 1811017
ChinaSite Not Available
The Third People's Hospital of Zhenjiang
Zhenjiang, Jiangsu
ChinaSite Not Available
The Third People's Hospital of Zhenjiang
Zhenjiang 1784642, Jiangsu 1806260
ChinaSite Not Available
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310052
ChinaSite Not Available
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou 1808926, Zhejiang 1784764 310052
ChinaSite Not Available

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