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
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 50 Healthy Volunteers (HV). Part B: MAD study in approximately 30 adult participants living with Chronic Hepatitis B (CHB).
• 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.
• Able and willing to provide written informed consent.
• Male or female aged 18 to 70 years,
• BMI between 18 and 35 kg/m2.
• 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.
• Diagnosed with CHB and are HBeAg-negative (on 2 occasions at least 6 months apart) and have HBsAg titers of ≥ 100 IU/mL at Screening.
• Participants must be treatment naive (i.e., have never received treatment with HBV antiviral medicines \[NUCs, IFN\] or an investigational anti-HBV agent) or currently not treated (i.e., not been on treatment with approved \[NUCs, IFN\] or investigational anti-HBV medicines within 12 months prior to randomization).
• Vital signs and physical examination are normal, or abnormal values are not clinically significant in the opinion of the Investigator.