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

Phase 1

Recruiting

• Conditions: HEPATITIS B CHRONIC
• Interventions: Biological: PBGENE-HBV

• Registration Number: NCT06680232
• Lead Sponsor: Precision BioSciences, Inc.

Brief 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.

Detailed Description

Refer to key Inclusion and Exclusion criteria.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-11-06
• Study First Posted: 2024-11-08
• Study Start: 2024-11-14
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Participants in both Part 1 and 2 will receive a finite course of PBGENE-HBV.	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 Measures

Name	Time	Method
Safety to Assess Treatment-emergent Adverse Events (TEAEs)	4 weeks after final dose	Frequency of TEAEs

Secondary Outcome Measures

Name	Time	Method
Additional Safety	48 weeks	Frequency and severity of adverse events and changes in physical examinations, vital signs, and safety labs (hematology, chemistry, and urinalysis)
Pharmacokinetics of AUC	4 weeks	Total PBGENE-HBV exposure over time
Pharmacokinetics of Cmax	4 weeks	Time at which Cmax (maximum peak concentration of PBGENE-HBV) is observed
Pharmacokinetics of Cmin	4 weeks	Minimum (or trough) concentration of PBGENE-HBV
Pharmacokinetics of half life (t1/2)	4 weeks	Terminal half life
Antiviral Activity of HBsAg and Anti-HBs	48 weeks	Changes from baseline in hepatitis B surface antigen (HBsAg) and anti-HBs levels
Antiviral Activity of HBV DNA	48 weeks	Changes from baseline of HBV DNA

Trial Locations

Locations (3)

New Zealand Clinical Research; 🇳🇿 Auckland, New Zealand

Queen Mary Hospital, The University of Hong Kong; 🇭🇰 Pok Fu Lam, Hong Kong

ICS ARENSIA Exploratory Medicine SRL; 🇲🇩 Chisinau, Moldova, Republic of