NCT06680232RecruitingPhase 1
A Phase 1, Open-Label, First-in-Human, Dose Escalation (Part 1) and Expansion (Part 2) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of PBGENE-HBV in Participants With Chronic Hepatitis B (ELIMINATE-B)
Precision BioSciences, Inc.10 sites in 6 countries45 target enrollmentStarted: November 14, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Precision BioSciences, Inc.
- Enrollment
- 45
- Locations
- 10
- Primary Endpoint
- Safety to Assess Treatment-emergent Adverse Events (TEAEs)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
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.
Intervention: PBGENE-HBV (Biological)
Outcomes
Primary Outcomes
Safety to Assess Treatment-emergent Adverse Events (TEAEs)
Time Frame: 4 weeks after final dose
Frequency of TEAEs
Secondary Outcomes
- Additional Safety(48 weeks)
- Pharmacokinetics of AUC(4 weeks)
- Pharmacokinetics of Cmax(4 weeks)
- Pharmacokinetics of Cmin(4 weeks)
- Pharmacokinetics of half life (t1/2)(4 weeks)
- Antiviral Activity of HBsAg and Anti-HBs(48 weeks)
- Antiviral Activity of HBV DNA(48 weeks)
Investigators
Study Sites (10)
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