Набор скоро начнётся NCT07617194

Study of AHB-171 in Chronic Hepatitis B Participants

Фаза I С лечением Hepatitis B, Chronic

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: AHB-171, Placebo matching [Investigational Product], Nucleos(t)ide Analogue (NA).
Кому может быть актуально: Состояния в реестре: Hepatitis B, Chronic. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Гонконг, Новая Зеландия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 1 Study in Chronic Hepatitis B Participants to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AHB-171

Обзор

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AHB-171 in participants with chronic hepatitis B (CHB). Study advancement to subsequent parts/cohorts will require satisfactory interim reviews of available cumulative safety data by the Safety Review Committees (SRC), using the safety criteria and review procedures described in the protocol.

Вмешательства

Препарат AHB-171
Injection
Препарат Placebo matching [Investigational Product]
Injection
Препарат Nucleos(t)ide Analogue (NA)
Oral administration

Первичные конечные точки

Incidence of Adverse Events (AEs) [Safety and Tolerability] [Срок оценки: Up to 72 weeks]
The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the maximum observed plasma concentration (Cmax) of AHB-171. [Срок оценки: Up to 72 weeks]
The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: the area under the concentration-time curve extrapolated to infinity (AUCinf ) of AHB-171 [Срок оценки: Up to 72 weeks]
Incidence of clinically significant changes in Vital Signs [Safety and Tolerability] [Срок оценки: Up to 72 weeks]
Incidence of clinically significant changes in cardiac parameters [Safety and Tolerability] [Срок оценки: Up to 72 weeks]
Incidence of laboratory abnormalities [Safety and Tolerability] [Срок оценки: Up to 72 weeks]
The plasma pharmacokinetic (PK) profile of AHB-171 and metabolites: area under the curve from the time of dosing to the last measurable concentration (AUClast) of AHB-171 [Срок оценки: Up to 72 weeks]

Вторичные конечные точки (12)

Absolute serum HBsAg (Hepatitis B surface antigen) and change from baseline across all evaluated timepoints in the study [Срок оценки: Up to 72 weeks]
Absolute serum HBV (Hepatitis B virus) DNA and change from baseline across all evaluated timepoints in the study. [Срок оценки: Up to 72 weeks]
Absolute serum HBeAb (Hepatitis B e Antibody) and change from baseline across all evaluated timepoints in the study. [Срок оценки: Up to 72 weeks]
Proportion of participants achieving pre-specified HBsAg reduction levels or absolute thresholds across all evaluated timepoints in the study. [Срок оценки: Up to 72 weeks]
Proportion of participants achieving HBsAg < or ≥ LOD (limit of detection) and/or HBV DNA < or ≥ LLOQ (lower limit of quantitation) across all evaluated timepoints in the study. [Срок оценки: Up to 72 weeks]
Proportion of participants achieving pre-specified HBV DNA levels or absolute thresholds across all evaluated timepoints in the study. [Срок оценки: Up to 72 weeks]
Time to achieving pre-specified HBsAg levels or absolute thresholds across all evaluated timepoints in the study [Срок оценки: Up to 72 weeks]
Change from baseline in alanine aminotransferase (ALT) levels [Срок оценки: Up to 72 weeks]
Proportion of participants with ALT normalization among those with elevated ALT at baseline across all evaluated timepoints in the study. [Срок оценки: Up to 72 weeks]
Proportion of participants achieving anti-HBs seroconversion across all evaluated timepoints in the study. [Срок оценки: Up to 72 weeks]
Proportion of participants experiencing virologic relapse. [Срок оценки: Up to 72 weeks]
Time to participants experiencing virologic relapse. [Срок оценки: Up to 72 weeks]

Критерии участия

Критерии включения

Male or female participants, aged 18-65 years old (inclusive)
Body Mass Index between 19 to 35 kg/m2 (inclusive)
Body weight > or = 45 kg.
Documented HBV infection for ≥6 months prior to randomization.
For Parts A and B, on stable approved NA monotherapy for at least 6 months prior to randomization.
For Part C and D only, not on any NA monotherapy for at least 6 months prior to randomization.
Screening electrocardiogram (ECG) without clinically significant abnormalities
Females of childbearing potential must not be breastfeeding, must have a negative serum pregnancy test at Screening, and a negative urine/serum pregnancy test before dosing (unless permanently sterile or >2 years postmenopausal).
Males and females of childbearing potential must agree to use protocol specified reliable contraception throughout the study.
Screening HBV DNA, HBsAg and ALT must meet prespecified requirements.

Критерии исключения

Significant medical conditions other than chronic HBV (e.g. recent heart issues, unstable cardiac disease, uncontrolled diabetes, bleeding disorders, prior organ transplant).
Other clinically significant liver diseases (e.g. hepatitis from other causes, autoimmune or alcoholic liver disease, prior liver failure).
History of suspected or confirmed cirrhosis (based on FibroScan® or biopsy).
Current, past, or suspected liver cancer, or elevated alpha-fetoprotein (AFP) ≥ 20 ng/mL.
HBV-related extrahepatic diseases (e.g. kidney or vascular conditions).
Severe infection (other than chronic HBV infection) within 1 month before randomization requiring intravenous treatment.
Active infections: human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV) or syphilis (exceptions if RNA negative).
Abnormal lab results (e.g. low albumin, reduced kidney function, abnormal INR, low platelets, high bilirubin, abnormal blood counts, significant proteinuria).
History or signs of vasculitis or related autoimmune diseases.
Malignancy within 5 years (except non-melanoma skin cancer).
Allergy to study drug components.
Recent major surgery/trauma (within 3 months) or planned surgery during study.
Alcohol or substance abuse affecting compliance.
Pregnancy, breastfeeding, or unwillingness to follow reproductive restrictions.
Participation in another clinical trial or recent investigational product use.
Prior treatment with any antisense oligonucleotide or small interfering RNA therapies.
Recent or ongoing use of immunosuppressive/biologic therapies, certain vaccines, bulevirtide, or unapproved herbal remedies.
Need for long-term anticoagulants/antiplatelet drugs (unless safely stopped).
Any other condition making the participant unsuitable (per investigator).