Overview
This study will examine the safety and tolerability of single and multiple doses of IB-001, and will be conducted in two parts:
Part A: SAD study in approximately 60 Healthy Volunteers (HV). Part B: MAD study in approximately 30 adult participants living with Chronic Hepatitis B (CHB).
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 two parts:
Part A: Single Ascending Dose (SAD) in Healthy Volunteers Up to 60 healthy adult participants in up to six 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: Multiple Ascending Dose (MAD) in Treatment-Naïve or Currently-Not-Treated Adults with Chronic Hepatitis B (CHB) Up to 30 adult participants (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.
Eligibility
Inclusion Criteria:
- Able and willing to provide written informed consent.
- Male or female aged 18 to 70 years.
- Females must not be of childbearing potential OR those who are of childbearing potential must be non-pregnant and non-lactating and willing to use a highly effective method of contraception.
Males whose partners are of childbearing potential must either be surgically sterile or willing to use a highly effective acceptable method of contraception.
- Non-tattooed, clear injection site suitable for SC injection and monitoring in the opinion of the Investigator.
Exclusion Criteria:
Healthy participants must not meet any of the following criteria at Screening or upon admission to the site (on Day -1).
- Major surgery requiring general anesthesia within 12 weeks prior to Screening or is expected to have surgery requiring general anesthesia during the course of the study.
- History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents.
- Blood donation or blood loss of ≥ 1 unit (450 mL) of whole blood within 4 weeks before Screening or plasma donations within 7 days prior to dosing on Study Day 1.
- Any underlying medical condition (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrinological, tumor, pulmonary, immune, mental, or cardiovascular and cerebrovascular diseases).
- History of malignancy, except for non-melanoma skin cancer, excised more than 1 year prior to Screening or cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening.
- Current hepatitis A virus (HAV) infection, hepatitis B virus (HBV) infection , hepatitis C virus (HCV) infection , or hepatitis E virus (HEV) infection .Positive test for HIV-1 or HIV-2 antibodies.
- Any other active infection requiring systemic antiviral or antimicrobial therapy that will not be completed within 2 weeks of first dosing.
- Clinically significant 12-lead ECG abnormalities on Screening ECG.
- History of cardiac arrhythmias.
- Physical examination findings at Screening that are considered clinically significant by the Investigator and likely to adversely impact study conduct and/or interpretation.
- Clinically significant abnormal vital signs
- Laboratory examination abnormalities considered clinically significant by the Investigator at Screening.
- Use of any prescribed or over-the-counter medications (including vitamins or herbal remedies) within 2 weeks of first dosing or within 5 times the elimination half-life of the medication prior to first dosing.
- Any suspicion or history of drug and/or alcohol abuse within the last year.
- Pregnant, planning to become pregnant during the course of the study, or currently breastfeeding.
