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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPrecision BioSciences, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • PBGENE-HBV

Treatment groups

45 Participants
are divided into 1 treatment group

Sponsors and collaborators