๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
PART A and Part C: Healthy Volunteers
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 Volunteer 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 โฅ 1 unit (450 mL) of whole blood within 4 weeks before Screening or plasma donations within 7 days prior to dosing of investigational product (IP).
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.
7. Positive test for HIV-1 or HIV-2 antibodies.
8. Any other active infection requiring systemic antiviral or antimicrobial therapy that will not be completed within 2 weeks of first dosing.
9. Clinically significant abnormalities on Screening ECG or history of cardiac arrhythmias, risk factors for Torsade de Pointes (hypokalemia, hypomagnesemia, decompensated heart failure and acute myocardial infarction), and a QTcF \> 450 ms (males) or QTcF \> 470 ms (females) at Screening.
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 abnormalities considered clinically significant by the Investigator at Screening. From Cohort A3 onwards, participants with blood platelet counts \< 150 ร 109/L or absolute neutrophil counts \< 1.5 ร 109/L will be excluded.
13. Receipt of any investigational drug or product within 90 days of Study Day 1 or within 5 times the elimination half-life of the medication prior to first dosing with the IP, whichever is earlier. Receipt of an invasive medical device within 90 days before first dosing with the IP that in the opinion of the PI or designee may impact the ability of the participant to complete all protocol-required procedures. Participants must not have participated in interventional clinical studies more than 4 times per year.
14. 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.
15. Has received live vaccine(s) within 28 days of Screening or plans to receive live vaccines within 28 days of dosing with the IP on Study Day 1. Note: COVID-19 vaccines are not considered live vaccines.
16. Any suspicion or history of drug and/or alcohol abuse within the last year.
17. Positive toxicology Screening panel (urine test including qualitative identification of tetrahydrocannabinol, cocaine, amphetamines, benzodiazepines, opiates, methadone, methamphetamines, ecstasy, and phencyclidine).
18. Positive alcohol breath test at Screening and/or on Study Day -1.
19. History (within 90 days of Screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol). Alcohol consumption will be prohibited at least 48 hours before dosing with the IP on Study Day 1, and during the in-house stay at the clinical research unit.
20. Uses more than 5 cigarettes, or equivalent, per day in the 3 months prior to Screening, and/or is unwilling to abstain from nicotine-containing products for 48 hours prior to admission to the site and during the in-house stay at the clinical research unit.
21. Pregnant or planning to become pregnant during the course of the study, or currently breastfeeding.
22. Any other factor that makes it inappropriate for study participation per the Investigator's judgment.
For Part C Only:
23. Clinically significant retinal disease; severe, uncontrolled, or unstable psychiatric illness, including major depression; uncontrolled thyroid disease or clinically significant abnormalities in thyroid stimulating hormone (TSH) or free T4, per Investigator's judgment.
24. Known hypersensitivity to peginterferon alfa-2a, interferons, PEG, or any component of the IP formulation.
25. Any other contraindications listed in the peginterferon alfa-2a product Data Sheet per Investigator's judgment
PART B: Participants with Chronic Hepatitis B (CHB)
Inclusion Criteria:
1. Able and willing to provide written informed consent.
2. Male or female aged 18 to 70 years,
3. BMI between 18 and 35 kg/m2.
4. 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.
5. Diagnosed with CHB and are HBeAg-negative (on 2 occasions at least 6 months apart)