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

RecruitingPhase 1Ages 18 Years - 70 YearsAllPrecision BioSciences, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • PBGENE-HBV
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Where

7 sites
Massachusetts General Hospital/Harvard University
Boston, United States
Hospital Beaujon
Clichy, France
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
ICS ARENSIA Exploratory Medicine SRL
Chisinau, Moldova
New Zealand Clinical Research
Auckland, New Zealand
ARENSIA Exploratory Medicine
Bucharest, Romania
Arensia Exploratory Medicine in collaboration with County Clinical Emergency Hospital
Cluj-Napoca, Romania
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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