IB-001 dose response and tolerability in healthy adults and people with chronic hepatitis B
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 first-in-human test gives single and weekly injected doses of IB-001 to see if they are safe and tolerated in healthy adults and adults living with chronic hepatitis B.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | IntegerBio Industry-sponsored |
| Locations | 1 site (Auckland, Auckland) |
| Trial ID | NCT07389044 on ClinicalTrials.gov |
What this trial studies
This double-blind, randomized, placebo-controlled Phase 1 study administers subcutaneous IB-001 to characterize safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary antiviral activity. Part A is a single-ascending-dose (SAD) escalation in up to ~60 healthy volunteers across up to six cohorts with a 28-day follow-up. Part B is a multiple-ascending-dose (MAD) escalation in up to ~30 adults with chronic hepatitis B across three cohorts receiving once-weekly doses for four weeks with a six-week post-treatment follow-up. Dose escalation decisions for both parts are made by a Safety Review Committee based on emerging safety data.
Who should consider this trial
Good fit: Ideal candidates are adults 18–70 who can consent, have a suitable clear subcutaneous injection site, and either are healthy volunteers (Part A) or adults with chronic hepatitis B who are treatment‑naïve or not currently receiving therapy (Part B).
Not a fit: People currently on HBV treatment, with recent major surgery, a history of severe allergic reactions, an unsuitable injection site, or other exclusion criteria are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, IB-001 could offer a new antiviral approach for people with chronic hepatitis B and guide dosing for later trials.
How similar studies have performed: Other first-in-human dose-escalation studies of experimental HBV therapeutics have sometimes shown preliminary antiviral signals but results vary and the approach remains experimental.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Auckland, Auckland
- New Zealand Clinical Research — Auckland, Auckland, New Zealand (Recruiting)
Study contacts
- Principal investigator: Edward Gane, MBChB, MD, FRACP, MNZ — New Zealand Clinical Research
- Study coordinator: Carey Hwang, MD, PhD
- Email: ClinOps@integer.bio
- Phone: +1 615 491 2553
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.