A Study on IB-001 Dose Response and Tolerability in Healthy Adults and Those With Chronic Hepatitis B
brief summary
This study will examine the safety and tolerability of single and multiple doses of IB-001 in two parts: Part A: SAD study in approximately 50 Healthy Volunteers (HV). Part B: MAD study in approximately 30 adult participants living with Chronic Hepatitis B (CHB). A separate exploratory, open-label, single-dose cohort (Part C) will evaluate pegylated interferon alfa-2a in HVs for translational benchmarking against IB-001.
detailed description
This is a first-in-human, double-blind, randomized, placebo-controlled Phase 1 study of IB-001 administered subcutaneously to evaluate safety, tolerability, PK/PD, and preliminary antiviral activity.
The study is comprised of three parts:
Part A: Single-dose, multicohort, dose-finding study in approximately 50 adult Healthy Volunteers (HV) in up to five cohorts (n=10 per cohort; 8 active:2 placebo). Participants will receive a single sub-cutaneous dose of investigational product followed by a 28-day post treatment follow-up.
Part B: Multidose, multicohort study in Treatment-Naïve or Currently-Not-Treated Adults with Chronic Hepatitis B (CHB).
Approximately 30 adult participants (up to 3 cohorts; n=10 per cohort; 8 active:2 placebo). Once-weekly sub-cutaneous dosing over 4 weeks with 6-week post-treatment follow-up. Dose recommendations in both Part A and Part B will be made by the Safety Review Committee (SRC) based on review of emerging safety data.
Part C: Single-dose, open label, single cohort study in approximately 8 adult Healthy Volunteers (HV). Participants will receive a single sub-cutaneous dose of peginterferon alfa-2a followed by a 14 day post treatment follow-up.
official title
A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, And Preliminary Efficacy of Single and Multiple Ascending Doses of IB-001 in Healthy Participants and Participants With Chronic Hepatitis B