A Study on IB-001 Dose Response and Tolerability in Healthy Adults and Those With Chronic Hepatitis B

This is a first‐in‐human, double‐blind, randomized, placebo‐controlled Phase 1 study ofIB‐001 administered subcutaneously to evaluate safety, tolerability, PK/PD, andpreliminary antiviral activity.The study is comprised of two parts:Part A: Single‐dose, multicohort, dose‐finding study in approximately 50 adult HealthyVolunteers (HV) in up to five cohorts (n=10 per cohort; 8 active:2 placebo). Participantswill receive a single sub‐cutaneous dose of investigational product followed by a 28‐daypost treatment follow‐up.Part B: Multidose, multicohort study in Treatment‐Naïve or Currently‐Not‐Treated Adultswith Chronic Hepatitis B (CHB).Approximately 30 adult participants (up to 3 cohorts; n=10 per cohort; 8 active:2placebo). Once‐weekly sub‐cutaneous dosing over 4 weeks with 6‐week post‐treatmentfollow‐up. Dose recommendations in both Part A and Part B will be made by the SafetyReview Committee (SRC) based on review of emerging safety data.