Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
NCT ID:
NCT07069569
Eligibility Criteria:
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;
* Aged between 18 and 65 years at the time of signing the ICF;
* Body mass index (BMI) within the range of 18-30 kg/ m2;
* HBeAg negative at screening;
* HBsAg or HBV DNA positive for at least 6 months;
* Continue antiviral therapy with a single nucleoside (t) ide analogue for more than 6 months prior to screening;
* Alanine aminotransferase (ALT) ≤ 2 × upper limit of normal (ULN);
* Effective contraception as required.
Exclusion Criteria:
* Participants who are not eligible for treatment with Peg-IFN/recombinant hepatitis B vaccine;
* Clinically significant abnormalities other than a history of chronic HBV infection;
* Concomitant clinically significant other liver diseases;
* Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to screening;
* HCV RNA positive, Human immunodeficiency virus (HIV) positive, syphilis positive;
* Significant liver fibrosis or cirrhosis at screening, or a liver stiffness value (LSM) \> 9.0 kPa;
* Previous/current manifestations of hepatic decompensation;
* Diagnosis or suspicion of hepatocellular carcinoma, or alpha-fetoprotein concentration (AFP) ≥ 20 ng/mL at screening;
* Obviously abnormal laboratory test results;
* History of vasculitis or presence of signs, symptoms, or laboratory tests of underlying vasculitis, and previous/current other diseases that may be related to vasculitic conditions;
* QT interval corrected for heart rate (Fridericia method) abnormal;
* History of extrahepatic disease possibly related to HBV immune status;
* Participants with a history of malignancy within the past 5 years or who are being evaluated for a possible malignancy;
* Serious mental illness or history of serious mental illness prior to screening;
* Suspected history of allergy to any component of the study drug, or allergic constitution;
* Major trauma or major surgery within 3 months prior to screening, or planned surgery during the study;
* Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
* Current use or use of any immunosuppressive medication within 3 months prior to screening, with the exception of short courses (≤ 2 weeks) or use of topical/inhaled steroids;Those who have used immunomodulators and cytotoxic drugs within 6 months prior to the first dose;Or a history of vaccination within 6 months prior to screening or a live vaccination plan during the trial;
* Participants requiring regular long-term administration of anticoagulants or antiplatelet drugs;
* Thyroid dysfunction;
* Patients with uncontrolled epilepsy and other progressive neurological disorders;
* Received any antisense oligonucleotides (ASO) or small molecule interfering ribonucleic acid (siRNA) drug;
* Any other circumstance or condition that, in the opinion of the investigator, the participants are inappropriate for participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07069569
Study Brief:
Protocol Section:
NCT07069569