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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.
Refer to key Inclusion and Exclusion criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants in both Part 1 and 2 will receive a finite course of PBGENE-HBV. | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBGENE-HBV | Biological | PBGENE-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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety to Assess Treatment-emergent Adverse Events (TEAEs) | Frequency of TEAEs | 4 weeks after final dose |
| Measure | Description | Time Frame |
|---|---|---|
| Additional Safety | Frequency and severity of adverse events and changes in physical examinations, vital signs, and safety labs (hematology, chemistry, and urinalysis) | 48 weeks |
| Pharmacokinetics of AUC |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Precision Trial Manager | Contact | 800-371-8953 | ELIMINATE-B@precisionbiosciences.com |
| Name | Affiliation | Role |
|---|---|---|
| Stanley Frankel, MD Medical Monitor | Precision BioSciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital/Harvard University | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Part 1 is to identify a safe and well tolerated dose regimen of PBGENE-HBV Part 2 is an expansion cohort to aid in selecting a dosing regimen.
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Total PBGENE-HBV exposure over time
| 4 weeks |
| Pharmacokinetics of Cmax | Time at which Cmax (maximum peak concentration of PBGENE-HBV) is observed | 4 weeks |
| Pharmacokinetics of Cmin | Minimum (or trough) concentration of PBGENE-HBV | 4 weeks |
| Pharmacokinetics of half life (t1/2) | Terminal half life | 4 weeks |
| Antiviral Activity of HBsAg and Anti-HBs | Changes from baseline in hepatitis B surface antigen (HBsAg) and anti-HBs levels | 48 weeks |
| Antiviral Activity of HBV DNA | Changes from baseline of HBV DNA | 48 weeks |
| Queen Mary Hospital, The University of Hong Kong | Recruiting | Hong Kong | Hong Kong | Hong Kong |
|
| ICS ARENSIA Exploratory Medicine SRL | Recruiting | Chisinau | 2025 | Moldova |
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| New Zealand Clinical Research | Recruiting | Auckland | 1010 | New Zealand |
|
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |