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

Summary

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).

Eligibility

Inclusion Criteria:

1. Able and willing to provide written informed consent.
2. Male or female aged 18 to 70 years.
3. 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.
4. 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).

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.
2. History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents.
3. 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.
4. Any underlying medical condition (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrinological, tumor, pulmonary, immune, mental, or cardiovascular and cerebrovascular diseases).
5. 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.
6. 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.
7. Any other active infection requiring systemic antiviral or antimicrobial therapy that will not be completed within 2 weeks of first dosing.
8. Clinically significant 12-lead ECG abnormalities on Screening ECG.
9. History of cardiac arrhythmias.
10. Physical examination findings at Screening that are considered clinically significant by the Investigator and likely to adversely impact study conduct and/or interpretation.
11. Clinically significant abnormal vital signs
12. Laboratory examination abnormalities considered clinically significant by the Investigator at Screening.
13. 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.
14. Any suspicion or history of drug and/or alcohol abuse within the last year.
15. Pregnant, planning to become pregnant during the course of the study, or currently breastfeeding.

Conditions2

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