Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06680232 | Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B | PHASE1 | RECRUITING | 45 | — | — | Nov 14, 2024 | Dec 1, 2026 | Sep 26, 2025 | 4 | United States, Hong Kong +2 |
Frequency of TEAEs
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| 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. |
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 Excl...