Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chro… (NCT06680232) | Clinical Trial Compass
RecruitingPhase 1
Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B
United States, Hong Kong, Moldova45 participantsStarted 2024-11-14
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Safety to Assess Treatment-emergent Adverse Events (TEAEs)