Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Precision BioSciences, Inc.
- Study ID
- NCT06680232
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- HEPATITIS B CHRONIC
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- PBGENE-HBV — BIOLOGICALPBGENE-HBV is an in vivo gene editing intervention based on a novel proprietary ARCUS® platform designed to potentially cure chronic hepatitis B virus (HBV) by eliminating cccDNA, the key source of replicating hepatitis B virus, while also inactivating integrated HBV DNA in hepatocytes.
Study Details
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.
Key Dates
- Start date
- Nov 14, 2024
- Status verified
- Sep 2025
- Primary completion
- Dec 31, 2025
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 45 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Participants in both Part 1 and 2 will receive a finite course of PBGENE-HBV.All participants will receive a finite course of multiple IV dose administrations of PBGENE-HBV. In Part 1, this will be done in a dose escalation manner which may be evaluated further in a Part 2 expansion cohort.
Primary Outcome Measure
Safety to Assess Treatment-emergent Adverse Events (TEAEs) [ Time Frame: 4 weeks after final dose ]
Central Contacts
- Precision Trial Manager800-371-8953
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Massachusetts General Hospital/Harvard University | Boston | Massachusetts | 02114 | Raymond T Chung, MD (PRINCIPAL_INVESTIGATOR) |
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