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Набира участници Фаза 1 NCT06680232

Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: HEPATITIS B CHRONIC

Спонсор: Precision BioSciences, Inc.

Налично на: БГ
Обобщение
This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B.
Описание
Refer to key Inclusion and Exclusion criteria.
Кой може да участва
Key Inclusion Criteria: * Male or women of non-child bearing potential * BMI 18.0 to 35.0 * Good overall health deemed by the study Investigator * CHB infection documented at least 12 months prior to screening * HBeAg-negative CHB * Must be virologically suppressed on current NA treatment Key Exclusion Criteria: * No history of cirrhosis of the liver * No current infections of Hepatitis A, D, and E, human immunodeficiency virus (type 1 and 2), and no history of or current hepatitis C. In addition, no other active infections deemed clinically relevant. * No signs of hepatocellular carcinoma * Not received an organ transplant * No malignancy within 5 years of screening, except for specific cancers that are cured by surgical resection (e.g., basal cell skin cancer) * No investigational agent received within 6 months of screening
Места на провеждане 4
Hong Kong (1)
Queen Mary Hospital, The University of Hong Kong
Hong Kong , Hong Kong
Man-Fung Yuen, MBBS, MD, PhD, DSc
Moldova (1)
ICS ARENSIA Exploratory Medicine SRL
Chisinau
Manager, Projects & Research Logistics
New Zealand (1)
New Zealand Clinical Research
Auckland
САЩ (1)
Massachusetts General Hospital/Harvard University
Boston , Massachusetts
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
70 Years
Здрави доброволци
Не
Начална дата
14.11.2024
Крайна дата
01.12.2026
Регистрационен номер
NCT06680232
Източник
anzctr
Запитване за медицински туризъм

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