Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With Chronic… (NCT06829329) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With Chronic Hepatitis B (CHB)
China105 participantsStarted 2024-12-13
Plain-language summary
The study is to evaluate the efficacy and safety of AHB-137 in CHB participants. The total duration of the study, including screening phase, treatment phase and follow-up phase.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Participants voluntarily participate in the study, and sign the Informed Consent Form (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) at the time of signing the ICF;
* Male participants weighed higher than 50 kg and female participants weighted higher than 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 months prior to screening and has not received antiviral treatment with interferon or NAs ;
* At screening, ALT\<3Ă—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 Criteria:
* Clinically significant abnormalities except chronic HBV infection;
* Any clinically significant liver diseases;
* Participants with severe infection requiring systemic anti-infection treatment 1 month 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 immuno…
What they're measuring
1
Proportion of participants achieving HBsAg lower than limit of detection (LOD) (0.05 IU/mL) and HBV DNA lower than lower limit of quantitation (LLOQ).