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)
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
United States
Massachusetts
Massachusetts General Hospital/Harvard University
RECRUITING
Boston
Other Locations
Hong Kong Special Administrative Region
Queen Mary Hospital, The University of Hong Kong
RECRUITING
Hong Kong
New Zealand
New Zealand Clinical Research
RECRUITING
Auckland
Republic of Moldova
ICS ARENSIA Exploratory Medicine SRL
RECRUITING
Chisinau
Contact Information
Primary
Precision Trial Manager
ELIMINATE-B@precisionbiosciences.com
800-371-8953
Time Frame
Start Date: 2024-11-14
Estimated Completion Date: 2026-12
Participants
Target number of participants: 45
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Precision BioSciences, Inc.