Kronik Hepatit B Olan Katılımcılarda Çoklu Kombinasyon Tedavilerinin Etkililiğini ve Güvenliliğini Değerlendiren Çalışma

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Body mass index between 18 and 32 kg/m2 inclusive.
* Participants with Chronic Hepatitis B (CHB) infection (HBsAg positive for \>=6 months) who are on established NUC (entecavir or tenofovir alafenamide/disoproxil fumarate) monotherapy for \>=12 months, having received the same NUC therapy for \>=3 months prior to screening.
* HBV DNA below the lower LLOQ or \< 20 IU/mL for \> 6 months prior to screening and confirmed at screening.
* Alanine transaminase (ALT) \<=1.5 x upper limit of normal (ULN) for \> 6 months prior to screening and confirmed at screening.
* Female Participants: Eligible to participate if she is not pregnant, not breastfeeding and agrees to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods.
* Male Participants: During the treatment period and for at least 6 months after the final dose of study treatment, agrees to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm.

Exclusion Criteria:

* Pregnant or lactating women.
* Co-infection with other pathogens such as Hepatitis A, C, D and E or Human Immunodeficiency Virus (HIV).
* History of cirrhosis or current evidence of significant liver fibrosis or cirrhosis or decompensated liver disease.
* History of or suspicion of Hepatocellular Carcinoma (HCC).
* Thyroid disease poorly controlled on prescribed medications or clinically relevant abnormal thyroid function tests.
* Clinically significant disease other than CHB that, in the opinion of the Investigator, makes the participant unsuitable for the study.
* Pre-existing cardiac disease that in the opinion of the investigator would increase the risk for the participant to take part in the study.
* History of alcohol abuse and/or drug abuse within one year of randomization.
* History of having received (in the last 6 months) or currently receiving any systemic antineoplastic (including radiation) or immunosuppressive (including biologic immunosuppressors) or immune modulating treatment.
* Currently taking, or have received within 3 months of Day 1, systemic corticosteroids.
* Electrocardiogram (ECG) with clinically significant abnormalities.
* Previous treatment with an investigational agent for Hepatitis B (HBV) within 6 months prior to screening.