| Спонсоры |
Ведущий спонсор: Arbutus Biopharma Corporation |
|---|---|
| Источник | Arbutus Biopharma Corporation |
| Краткое содержание | This three-part, Phase 1 protocol will be the first clinical study of AB-836. Parts 1 and 2 will be a Phase 1a SAD/MAD of AB-836 in healthy adult subjects. Part 3 will be a Phase 1b dose-ranging assessment of AB-836 in non-cirrhotic Chronic Hepatitis B (CHB) subjects. |
| Общий статус | Recruiting | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Дата начала | 2021-03-25 | ||||||||
| Дата завершения | 2022-08-01 | ||||||||
| Дата первичного завершения | 2022-04-01 | ||||||||
| Фаза | Phase 1 | ||||||||
| Тип исследования | Interventional | ||||||||
| Первичный результат |
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| Регистрация | 60 |
| Состояние |
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|---|---|
| Вмешательство |
Тип вмешательства: Drug Название вмешательства: AB-836 Описание: Capsules or Tablets Тип вмешательства: Drug Название вмешательства: Placebo Описание: Capsules or Tablets Тип вмешательства: Drug Название вмешательства: Tenofovir Disoproxil Fumarate Описание: Tablets Этикетка Arm Group: Part 3 (Chronic Hepatitis B [CHB] Participants): MAD Cohort J |
| Приемлемость |
Критерии: Inclusion Criteria: - Healthy Subjects 1. Male subjects or female subjects not of childbearing potential between 18 and 45 years old. 2. Free from clinically significant illness or disease as determined by their medical history, physical examination, vital signs, and clinical laboratory test results. 3. BMI of 18-32 kg/m2. - CHB Subjects: 1. Male or female between 18 and 65 years old. 2. Chronic HBV infection documented as a positive HBsAg, HBV DNA, or HBeAg test at least 6 months prior to the Screening Visit, or a historical liver biopsy consistent with chronic HBV infection 3. For cohort F, G, H and J: 1. HBV DNA ≥2,000 IU/mL at Screening (subjects may be either treatment-naïve or treatment-experienced but currently off-treatment). 2. ALT ≤ 5x ULN 4. For Cohort I: 1. HBV DNA Пол: All Минимальный возраст: 18 Years Максимальный возраст: 65 Years Здоровые волонтеры: Accepts Healthy Volunteers |
| Общий контакт |
Фамилия: Arbutus Biopharma Телефон: 267-469-0914 |
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| Расположение |
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| Расположение Страны |
Hong Kong Moldova, Republic of New Zealand Ukraine |
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| Дата проверки |
2021-06-01 |
| Ответственная сторона |
Тип: Sponsor |
| Имеет расширенный доступ | No |
| Состояние Просмотр |
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| Количество рук | 5 |
| Группа вооружений |
Метка: Part 1 (Healthy Subjects): Single Ascending Dose (SAD) Тип: Experimental Описание: Two cohorts (Cohorts A and B) of healthy subjects will receive single doses of AB-836/placebo in an alternating cohort design under fasted conditions. One additional treatment will be administered under fed conditions. Метка: Part 2 (Healthy Subjects): Multiple Ascending Dose (MAD) Тип: Experimental Описание: Participants in Cohorts C, D and E will receive a once daily dose of AB-836/placebo for 10 days Метка: Part 3 (Chronic Hepatitis B [CHB] Participants): MAD Cohorts F-H Тип: Experimental Описание: Participants in Cohorts F, G, and H will receive multiple doses of AB-836/placebo once daily for 28 days. Метка: Part 3 (Chronic Hepatitis B [CHB] Participants): MAD Cohort I Тип: Experimental Описание: Participants in Cohort I will receive multiple doses of AB-836/placebo once daily for 28 days in combination with ongoing nucleos(t)ide analog (NA) therapy. Метка: Part 3 (Chronic Hepatitis B [CHB] Participants): MAD Cohort J Тип: Experimental Описание: Participants in Cohort J will receive AB-836/placebo and TDF in combination once daily for 28 days. |
| Данные пациента | No |
| Информация о дизайне исследования |
Распределение: Randomized Модель вмешательства: Parallel Assignment Первичное назначение: Treatment Маскировка: Triple (Participant, Care Provider, Investigator) |